[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Boston Scientific Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":572},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,47,0,25,[9,39,65,84,116,146,171,198,217,238,256,274,299,327,358,378,401,420,439,460,481,503,520,529,554],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100054277","deep-brain-stimulation-dbs-retrospective-outcomes-study-100054277",false,"NCT03664609","Deep Brain Stimulation (DBS) Retrospective Outcomes Study","Inclusion Criteria:\n\n* Must be previously treated with or eligible for implantation with a deep brain stimulation system\n\nExclusion Criteria:\n\n* No Exclusion Criteria","ALL",{"count":18,"type":19},5000,"ESTIMATED","OBSERVATIONAL","The primary objective of this study is to characterize real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.",[23,24,25],"Parkinson Disease","Essential Tremor","Dystonia","RECRUITING","2026-07-10",{"date":29,"type":30},"2026-07-13","ACTUAL",{"date":32,"type":30},"2019-03-12",{"date":34,"type":19},"2028-12",{"name":36,"class":37},"Boston Scientific Corporation","INDUSTRY",19,{"id":40,"slug":41,"hasResults":12,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":49,"studyType":20,"phases":4,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100053806","intracept-minimally-invasive-procedure-for-vertebrogenic-back-pain-100053806","NCT06827262","Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain","IMPROVE","Inclusion Criteria:\n\n* Study candidate is scheduled to be treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use (IFU).\n* Signed a valid, IRB\u002FEC-approved informed consent form.\n\nExclusion Criteria:\n\n* Meets any contraindications per locally applicable Instructions for Use (IFU).","18 Years",{"count":48,"type":19},1500,"60 Months","Compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.",[52,53],"Chronic Low-back Pain","Vertebrogenic Pain Syndrome",[55,56,57],"Intraosseous basivertebral nerve ablation","Axial low back pain","Low Back Pain",{"date":29,"type":30},{"date":60,"type":30},"2025-03-26",{"date":62,"type":19},"2034-07",{"name":36,"class":37},18,{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100054181","patient-retrospective-outcomes-pro-100054181","NCT01550575","Patient Retrospective Outcomes (PRO)","PRO","Key Inclusion Criteria:\n\n* Previously treated with or eligible for use with Boston Scientific Systems\n* 18 years of age or older at the start of Baseline",{"count":73,"type":19},15000,"This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.",[76],"Chronic Pain",{"date":29,"type":30},{"date":79,"type":30},"2012-04-03",{"date":81,"type":19},"2030-12",{"name":36,"class":37},144,{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":92,"targetDuration":94,"studyType":20,"phases":4,"briefSummary":95,"conditions":96,"keywords":102,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100053645","stone-and-laser-therapies-post-market-study-salt-100053645","NCT06982235","Stone and Laser Therapies Post-Market Study (SALT)","Stone and Laser Therapies Post-Market Study","SALT","Inclusion Criteria:\n\nFor urinary tract procedure cohort:\n\n1. Subject intends to undergo diagnostic and\u002For therapeutic urinary tract procedure with qualified BSC device(s)\n2. Subject is willing and able to complete all follow-up visits\n\nFor BPH cohort:\n\n1. Subject is ≥ 40 years of age\n2. Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms\n3. Subject intends to undergo BPH treatment with qualified BSC device(s)\n4. Subject is willing and able to complete all follow-up visits\n\nExclusion Criteria:\n\nFor urinary tract procedure cohort:\n\n1. Subject requires simultaneous surgical treatment for BPH\n2. Unwilling or unable to provide consent\n3. Any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)\n\nFor BPH cohort:\n\n1. Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi)\n2. Unwilling or unable to provide consent\n3. Any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)",{"count":93,"type":19},238,"12 Months","The objective of the SALT Study is to obtain post-market safety and device performance data for Boston Scientific's Stone and BPH study devices used during a diagnostic and\u002For therapeutic urinary tract procedure (e.g., transurethral or percutaneous access routes) or benign prostatic hyperplasia (BPH) treatment.",[97,98,99,100,101],"Benign Prostate Hypertrophy(BPH)","Renal Calculi","Ureteral Stones, Kidney Stones","Calculi, Urinary","Urinary Tract Procedure",[103,104,105,98,106,107,108,101],"BPH","Benign Prostatic Hyperplasia","Lithotripsy","Renal Calculus","Boston Scientific","Kidney Stone",{"date":29,"type":30},{"date":111,"type":30},"2025-06-30",{"date":113,"type":19},"2029-02",{"name":36,"class":37},5,{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100598303","safety-and-effectiveness-of-left-bundle-branch-area-pacing-versus-conventional-cardiac-resynchronization-therapy-in-heart-failure-100598303","NCT07069738","Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure","SYNCHRONICITY","Inclusion Criteria:\n\n1. Patient is age 18 years or above, or of legal age to give informed consent specific to state and national law\n2. Patient meets a guideline-based indication for a de novo CRT-D device\n3. Primary prevention indication for ICD therapy\n4. Ischemic or nonischemic cardiomyopathy with LVEF ≤ 35% within 6 months of enrollment (LVEF must be assessed after the subject has been on GDMT for a minimum of 3 months) using an appropriate method of assessment (i.e. Echo, MRI, etc)\n5. NYHA class II-IV despite maximally tolerated guideline directed medical therapy (GDMT)\\* for at least 3 months\n\n   \\*GDMT is defined as all four drug classes listed below for at least 3 months prior to enrollment unless the investigator provides justification (e.g., contraindicated, not tolerated or cost): Renin Angiotensin System Inhibitors (ACE, ARB, or ARNI) Evidence based betablockers (metoprolol succinate, carvedilol, bisoprolol) Mineralocorticoid antagonists SGLT2 Inhibitor medications\n6. Sinus rhythm with left bundle branch block (LBBB) defined as a QRS ≥ 140 ms in men and ≥ 130 ms in women with a predominantly negative deflection (QS or rS in lead V1 and mid QRS notching or slurring in at least two of the following leads: 1, aVL, V1, V2, V5, V6) within 3 months of enrollment\n7. Patient is willing to participate in LATITUDE™ NXT remote patient monitoring\n8. Patient is willing and capable of providing informed consent and participating in all testing associated with this investigation at an approved study site and at the protocol defined intervals (Note: Use of a legally authorized representative (LAR) is not allowed)\n9. Patient plans to remain geographically stable (not permanently moving to another location) and can commit to all study participation requirements (procedure, follow-up visits and testing requirements)\n\nExclusion Criteria:\n\n1. Persistent or permanent atrial fibrillation (AF) within 3 months prior to enrollment and documented in the medical record\n2. Frequent premature ventricular contractions (PVCs), atrial arrhythmias, and\u002For other causes of expected percentage of cardiac physiologic pacing (CPP) delivery below 95% at the time of enrollment\n3. Non-LBBB conduction abnormalities (including right bundle branch block (RBB) or intraventricular conduction delay (IVCD)) within 3 months prior to enrollment\n4. Complete, second degree or high degree atrioventricular (AV) block, that requires pacing at the time of enrollment\n5. Current or prior pacemaker, ICD or CRT implant (Also includes non-transvenous ICD technology and leadless pacemakers)\n6. Prior or planned mechanical or bioprosthetic tricuspid valve replacement\n7. Currently receiving or previously received positive inotrope therapy within 3 months prior to enrollment\n8. Unstable angina, acute myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention within 3 months prior to enrollment\n9. History of heart transplantation or left ventricular assist device (LVAD) implantation\n10. Less than 1 year of life expectancy at the time of enrollment\n11. Anticipated heart transplantation or LVAD implantation within 1 year of enrollment\n12. History of ventricular septal defect (VSD)\n13. Complex congenital heart disease\n14. Documented diagnosis of cardiac amyloidosis\n15. Known occlusion or other reason limiting central venous access for transvenous leads\n16. Women of childbearing potential who are, or plan to become, pregnant during the course of the study (assessment per investigator's discretion)\n17. Patient currently requiring dialysis\n18. Patient with known or suspected sensitivity to Dexamethasone Acetate (DXA)\n19. Patient with contrast dye allergy or unwilling\u002Fable to undergo pre-treatment with steroids and\u002For diphenhydramine\n20. Inability or refusal to comply with the follow-up schedule including subject living at such a distance from the investigational site that attending follow-up visits would be unusually difficult or burdensome\n21. Patient is enrolled in any other concurrent study. Co-enrollment into other studies such as observational studies\u002Fregistries needs prior written approval by BSC. Local mandatory governmental registries are accepted for co-enrollment without approval by BSC.",{"count":124,"type":19},850,"INTERVENTIONAL",[127],"NA","This study will compare two different methods to pace the heart to treat heart failure including:\n\n1. The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left ventricle) to deliver heart failure therapy. This method is called Cardiac Resynchronization Therapy (CRT).\n2. The other method is using a lead implanted in the Left Bundle Branch Area (LBBA) of your heart. This method is called Left Bundle Branch Area Pacing or LBBAP. This lead is approved by the Food and Drug Administration (FDA) to be implanted in this area of the heart, but not to provide heart failure treatment.",[130],"Heart Failure - NYHA II - IV",[132,133,134,135,136],"Heart Failure","Conduction System Pacing","Primary Prevention","Cardiac Resynchronization Therapy","Left Bundle Branch Area Pacing","2026-07-01",{"date":139,"type":30},"2026-07-02",{"date":141,"type":30},"2025-10-22",{"date":143,"type":19},"2029-11",{"name":36,"class":37},35,{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":125,"phases":155,"briefSummary":156,"conditions":157,"keywords":160,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},"100589831","agent-dcb-stance-safety-and-effectiveness-study-of-agent-drug-coated-balloon-compared-to-standard-of-care-percutaneous-coronary-intervention-pci-treatment-for-de-novo-coronary-lesions-100589831","NCT06959524","AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions","AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease","Clinical Inclusion Criteria:\n\n* Subject must be at least 18 years of age.\n* Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed.\n* Subject is eligible for percutaneous coronary intervention (PCI).\n* Subject is willing to comply with all protocol-required follow-up evaluation.\n* Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.\n\nAngiographic Inclusion Criteria:\n\n* Target lesion is a de novo lesion located in a native coronary artery\n* Target lesion must have visually estimated stenosis \\> 50% and \\\u003C 100% in symptomatic subjects (\\>70% and \\\u003C100% in asymptomatic subjects) prior to lesion pre-dilation.\n* Target lesion must be successfully pre-dilated.\n* If a non-target lesion is treated, it must be treated first and must be deemed a success.\n\nClinical Exclusion Criteria:\n\n* Subject has other serious medical illness (e.g. cancer, congestive heart failure) that may reduce life expectancy to less than 12 months.\n* Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.).\n* Subject has planned procedure that may cause non-compliance with the protocol or confound data interpretation.\n* Subject is participating in another investigational drug or device clinical study that has not reached its primary endpoint.\n* Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure.\n* Subject is a woman who is pregnant or nursing. A pregnancy test must be performed within 7 days prior to the index procedure, except for women who definitely do not have child-bearing potential.\n* Subject has left ventricular ejection fraction known to be \\\u003C 30%.\n* Subject had PCI or other coronary interventions within the last 30 days.\n* Subject has planned PCI or CABG after the index procedure.\n* Subject had STEMI or QWMI \\\u003C72h prior to the index procedure.\n* Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically unstable.\n* Subject has cardiogenic shock (SBP \\\u003C 80 mmHg requiring inotropes, IABP or fluid support).\n* Subject has history (within 6 months prior to the index procedure) of New York Heart Association (NYHA) class III or IV heart failure.\n* Subject is considered not able to tolerate at least 30 seconds of coronary occlusion of the target lesion.\n* Subject has known allergy to paclitaxel or other components of the used medical devices.\n* Subject has known hypersensitivity or contraindication to contrast dye that in the opinion of the investigator cannot be adequately pre-medicated.\n* Subject has intolerance to antiplatelet drugs, anticoagulants required for procedure.\n* Subject has platelet count \\\u003C 100k\u002Fmm3 (risk of bleeding) or \\> 700k\u002Fmm3.\n* Subject with renal insufficiency (creatinine ≥2.0 mg\u002Fdl) or failure (dialysis dependent).\n\nAngiographic Exclusion Criteria:\n\n* In-stent restenosis.\n* Target lesion is located within a saphenous vein or arterial graft.\n* Target lesion is a total occlusion or has evidence of thrombus present in the target vessel.\n* Target lesion is severely calcified by angiography or has \\> 270° calcium arc on intravascular imaging or requires atherectomy.\n* Subject has unprotected left main coronary artery disease (\\>50% diameter stenosis) or three-vessel coronary disease requiring revascularization of all 3 vessels.\n* Subject with planned treatment of lesion involving aortic ostial location.",{"count":154,"type":19},1616,[127],"AGENT DCB STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled study designed to assess the safety and effectiveness of a treatment strategy with the AGENT Drug-Coated Balloon compared to standard of care percutaneous coronary intervention (PCI) treatment with drug eluting stent (DES) and\u002For balloon angioplasty in patients with de novo coronary lesions.\n\nSubjects must have a de novo target lesion located in a native coronary artery.",[158,159],"Coronary Arterial Disease (CAD)","de Novo Lesions in Native Coronary Arteries",[161,162,163],"Drug Coated Balloon","de novo","97279374",{"date":139,"type":30},{"date":166,"type":30},"2025-08-21",{"date":168,"type":19},"2032-03",{"name":36,"class":37},62,{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":125,"phases":181,"briefSummary":182,"conditions":183,"keywords":186,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":196,"locationsCount":197},"100607327","a-global-study-comparing-pulsed-field-ablation-with-electrographic-flow-mapping-versus-posterior-wall-ablation-for-persistent-atrial-fibrillation-100607327","NCT07187115","A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation","A Global Randomized Trial Comparing Pulsed Field Ablation of Pulmonary Veins Plus Extra-PV Sources Utilizing Electrographic Flow Mapping Versus Pulmonary Veins Plus Posterior Wall in Persistent Atrial Fibrillation Patients.","OPTIMIZE","Inclusion Criteria:\n\n1. ≥ 18 years of age, or older if required by local law\n2. Have symptomatic drug-refractory1, persistent AF2, confirmed by both:\n\n   * Documentation, such as physician note, of persistent continuous AF for \\> 7 days and ≤ 365 days and the arrhythmia symptoms\n   * Documentation, within 180 days of enrollment date of either:\n\n     * A 24-hour continuous ECG recording confirming continuous AF or\n     * Two (2) ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days apart\n3. Willing and capable of providing informed consent\n4. Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center\n5. Willing to receive LUX-Dx™ insertable cardiac monitor (ICM) during the study or already has a LUX-Dx™ ICM that was inserted ≤ 6 months (i.e., within 180 days) of consent, and willing to comply to the LUX-Dx Latitude Clarity transmission instructions\n\nExclusion Criteria:\n\n1. Any of the following atrial conditions:\n\n   1. Left atrial anteroposterior diameter ≥ 5.5 cm, or if1 LA diameter not available, non-indexed volume \\>100 ml (physician note or imaging)\n   2. Any prior left atrial ablation\n   3. Any prior atrial surgery\n   4. Current atrial myxoma\n   5. Current left atrial thrombus\n   6. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)\n2. Any of the following cardiovascular conditions:\n\n   1. History of sustained ventricular tachycardia or any ventricular fibrillation\n   2. Severe right ventricular dysfunction with documented echocardiography and\u002For hemodynamic data, per Investigator's discretion\n   3. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible \u002F non-cardiac causes\n   4. Cardiac devices and implants:\n\n      * Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices\n      * Implantable loop recorder, other than LUX-Dx\n      * Interatrial baffle, patent foramen ovale or atrial septal defect closure device or patch\n      * Any left atrial appendage closure or occlusion device\n   5. Presence of any of the following valvular conditions:\n\n      * Any prosthetic heart valve, stenotic valves, ring or repair\n      * Moderate to severe mitral valve stenosis\n      * More than moderate mitral regurgitation\n   6. Hypertrophic or amyloid cardiomyopathy\n   7. Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access\n   8. Awaiting cardiac transplantation or other planned cardiac surgery within the next 12 months\n   9. Severe right ventricular dysfunction with documented echocardiography and\u002For hemodynamic data.\n3. Any of the following conditions at Baseline:\n\n   1. Heart failure associated with NYHA Class III or IV\n   2. Most recent documented LVEF \\\u003C 40% within the previous 12 months\n   3. Body Mass Index (BMI) \\> 45.0\n   4. Known coagulopathy or bleeding disorder\n   5. Contraindication to, or unwillingness to use systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation\n   6. Women who are confirmed to be pregnant or lactating at the time of the ablation procedure\n   7. Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen\n   8. Active malignancy (other than squamous cell carcinoma)\n   9. Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration\n   10. Known active systemic infection\n   11. Untreated diagnosed obstructive sleep apnea with apnea hypopnea index classification of severe (\\>30 pauses per hour) as per the guidelines\n   12. Predicted life expectancy less than one year per investigator medical judgement\n   13. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility\n   14. Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure\n   15. Uncontrolled hypertension (SBP \\> 160 mmHg or DBP \\> 95 mmHg on two (2) BP measurements at baseline assessment not attributable to white coat syndrome per Investigator opinion\n   16. CHA2DS2-VASc score ≥ 5\n   17. Known allergic drug reaction to nitroglycerin (excluding hypotension)\n   18. Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx ICM device\n4. Any of the following congenital conditions:\n\n   1. Congenital heart disease with any clinically significant residual anatomic or conduction abnormality\n   2. History of known congenital methemoglobinemia\n   3. History of known G6PD deficiency\n5. Any of the following conditions in the medical history:\n\n   1. Solid organ or hematologic transplant, or currently being evaluated for a transplant\n   2. Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis\n   3. Any documented history of Prinzmetal Angina or severe non-revascularizable coronary disease\n   4. Renal insufficiency if an estimated glomerular filtration rate (eGFR) is \\\u003C 30 mL \u002F min \u002F 1.73 m2, or with any history of renal dialysis or renal transplant\n   5. Any other general health condition that, in the investigator's medical opinion, would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation.\n6. Any of the following events less than or equal to 90 days of the consent date:\n\n   1. Myocardial infarction (MI), unstable angina or coronary intervention\n   2. Any cardiac surgery\n   3. Heart failure hospitalization\n   4. Pericarditis or symptomatic pericardial effusion\n   5. Gastrointestinal bleeding\n   6. Stroke, TIA, or intracranial bleeding\n   7. Any active non-neurologic thrombus and\u002For thromboembolic event\n   8. Carotid stenting or endarterectomy\n   9. Uncontrolled diabetes mellitus or a recorded HbA1c \\> 8.0%",{"count":180,"type":19},699,[127],"The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources) and to demonstrate its non-inferiority in effectiveness compared to PFA of Pulmonary Veins and LA Posterior Wall (PVI+ PWA) in the treatment of de novo symptomatic drug-refractory persistent atrial fibrillation (PersAF).",[184,185],"Atrial Fibrillation (AF)","Persistant Atrial Fibrillation",[187,188,189],"FARAPULSE","FARAPOINT","OptiMap","2026-06-29",{"date":192,"type":30},"2026-06-30",{"date":194,"type":30},"2025-11-07",{"date":81,"type":19},{"name":36,"class":37},42,{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},"100289852","rhythmia-mapping-and-signal-acquisition-for-data-analysis-rhapsody-100289852","NCT03053141","RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)","RHAPSODY","Inclusion Criteria:\n\n1. Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law\n2. Scheduled for standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System.\n\nExclusion Criteria:\n\n1. Prothrombotic or bleeding tendency due to coagulopathy or blood dyscrasia\n2. Inability to tolerate heparin therapy (e.g. heparin induced thrombocytopenia, allergy, etc.)\n3. Prosthetic or stenotic valves in the chamber where the intended mapping will occur, or in the path of the catheter access route\n4. Active systemic infection or sepsis\n5. Hemodynamic instability or shock at baseline precluding ablation in the assessment of the investigator.\n6. Presence of intracardiac thrombus, tumor, or other abnormality which precludes catheter introduction\n7. Women who are pregnant or lactating\n8. Cardiac surgery within the past 90 days\n9. Acute myocardial infarction within 3 months\n10. Stable\u002Funstable angina or ongoing myocardial ischemia\n11. Subjects with an active heart failure decompensation\n12. Long QT Syndrome, Brugada Syndrome, or Torsade de Pointes\n13. Congenital heart disease with or without corrective surgery that would complicate a mapping procedure\n14. Subjects having untreatable allergy to contrast media\n15. Vascular pathology or tortuosity precluding standard vascular access techniques\n16. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.",{"count":206,"type":19},100,"The objective of the RHAPSODY study is to evaluate the performance of new software features in subjects undergoing standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System. Results from this study will be used to guide development and refinement of new software features that may be implemented in future commercial software releases.",[209],"Cardiac Arrythmias",{"date":192,"type":30},{"date":212,"type":30},"2016-05",{"date":214,"type":19},"2027-12",{"name":36,"class":37},8,{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":125,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":230,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":4},"100614224","overstitch-nxt-endoscopic-suture-system-100614224","NCT07276815","OverStitch NXT Endoscopic Suture System","Gathering of Results in Eligible Asian Obese Populations About Safety and Effectiveness of Overstitch ESG Trial","Inclusion Criteria:\n\n1. Aged 18 years or older, or subjects who have reached the legal age for signing informed consent in accordance with local laws and regulations.\n2. BMI ≥ 32.5 kg\u002Fm²; or BMI ≥ 27.5 kg\u002Fm² combined with type 2 diabetes mellitus (regardless of the effectiveness of medical treatment for type 2 diabetes); or BMI between 27.5 kg\u002Fm² and 32.5 kg\u002Fm² with ineffective medical weight loss or combined with other obesity-related diseases for which medical treatment is ineffective.\n3. Willing to comply with the long-term strict dietary restrictions required by the surgery.\n4. Capable of providing informed consent, able to complete all routine follow-up visits, and willing to abide by the protocol requirements, including signing the informed consent form, completing relevant examinations, and receiving dietary counseling.\n5. Females of childbearing potential (i.e., premenopausal or not sterilized) must agree to use adequate contraceptive measures.\n\nExclusion Criteria:\n\n1. History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)\n2. Prior gastrointestinal surgery with sequelae, i.e. obstruction, and\u002For adhesive peritonitis or known abdominal adhesions.\n3. Prior open or laparoscopic bariatric surgery.\n4. Prior surgery of any kind on the esophagus or any type of hiatal hernia surgery.\n5. Any inflammatory disease of the gastrointestinal tract including severe (LA Grade C or D) esophagitis, gastric ulceration, duodenal ulceration, specific inflammation such as Crohn's disease, and the doctor judges that it may affect the operation or efficacy of ESG.\n6. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresia or stenosis.\n7. History of gastrointestinal stromal tumors, gastrointestinal cancer, low-grade or high-grade gastric intraepithelial neoplasia, or familial or non-familial adenomatous polyposis syndrome.\n8. Gastric masses or untreated gastric polyps with a diameter \\> 1 cm.\n9. Hiatal hernia (Z-line displacement above the diaphragm \\> 4 cm) or severe\u002Frefractory gastroesophageal reflux symptoms, which the physician judges may affect the performance or prognosis of ESG.\n10. Structural abnormalities of the esophagus or pharynx that may impede endoscopic passage (e.g., strictures or diverticula), which the physician judges may affect the performance or prognosis of ESG.\n11. Gastrointestinal motility disorders (e.g., achalasia, severe esophageal motility disorders, gastroparesis, or intractable constipation), which the physician judges may affect the performance or prognosis of ESG.\n12. Evidence of untreated psychiatric or eating disorders, such as major depression, schizophrenia, substance abuse, binge eating disorder, or bulimia nervosa.\n13. Coagulopathy with INR \\> 1.5 that cannot be corrected (per physician's judgment) or requirement for continuous full anticoagulant therapy, and\u002For any underlying diseases associated with high bleeding risk.\n14. Insulin-dependent diabetes mellitus (type 1 or type 2), or high likelihood of requiring insulin therapy within the next 12 months.\n15. Decompensated cirrhosis, or acute\u002Fchronic liver dysfunction that the physician judges make the subject unsuitable for ESG treatment.\n16. Diagnosis of autoimmune connective tissue diseases (e.g., systemic lupus erythematosus, scleroderma) or immunocompromise, which the physician assesses may affect the performance or prognosis of ESG.\n17. Known history of endocrine diseases affecting body weight (e.g., Cushing's syndrome, uncontrolled hypothyroidism, or hyperthyroidism), which the physician assesses may affect the performance or prognosis of ESG.\n18. Anemia: Hemoglobin (Hgb) \\\u003C 110 g\u002FL for females; Hgb \\\u003C 120 g\u002FL for males.\n19. Any other medical conditions precluding elective endoscopy, such as poor general health, history of severe renal, hepatic, cardiac, and\u002For pulmonary diseases, and\u002For severe or uncontrolled psychiatric illnesses or abnormalities that may impair the patient's ability to understand or comply with follow-up visits and lifestyle interventions.\n20. Active psychological issues as determined by a psychologist or psychiatrist, precluding participation in lifestyle modification programs.\n21. Unwillingness to participate in the established medically supervised dietary and behavioral modification programs, as well as routine medical follow-up.\n22. Daily treatment with prescribed high-dose aspirin (\\> 80 mg per day), non-steroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, anticoagulants, corticosteroids, immunosuppressants, or other gastric irritant medications.\n23. Interval use of medications that may be affected by changes in gastric emptying (e.g., antiepileptic drugs or antiarrhythmic drugs).\n24. Inability or unwillingness to take prescribed proton pump inhibitor (PPI) medications.\n25. Current use of weight loss medications or other weight loss devices or use within the past 90 days.\n26. Current participation in a clinical trial involving investigational drugs or devices, or participation in such a trial within 30 days prior to enrollment in this study.\n27. Use of intragastric devices within 30 days prior to this study, which the physician assesses may affect the performance or prognosis of ESG.\n28. Unwillingness to avoid any reconstructive and\u002For plastic surgeries that may affect body weight during the study (e.g., mammoplasty, liposuction).\n29. Other conditions deemed unsuitable for endoscopy or ESG treatment by the investigator, including but not limited to conditions that the investigator believes may expose the subject to significant risks, confound study results, increase risks associated with endoscopy and\u002For endoscopic procedures, or substantially interfere with the subject's participation in the study.\n30. Pregnancy, lactation, or intention to become pregnant during the study (for females of childbearing potential).",{"count":225,"type":19},136,[127],"To demonstrate the safety and efficacy of OverStitch NXT Endoscopic Suture System for endoscopic sleeve gastroplasty（ESG） in obese populations to support the registration of OverStitch NXT for ESG indication.",[229],"Weight Loss","NOT_YET_RECRUITING","2026-06-28",{"date":192,"type":30},{"date":234,"type":19},"2026-07-31",{"date":236,"type":19},"2029-10-31",{"name":36,"class":37},{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":125,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},"100607988","orbera365-intragastric-balloon-system-abbreviated-asorbera365-100607988","NCT07195708","Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')","Clinical Study to Evaluate the Safety and Efficacy of the Orbera365 Intragastric Balloon System in Obese Patients","Inclusion Criteria:\n\n1. The subject is diagnosed with obesity, and the body mass index (BMI) is ≥28 kg\u002Fm² and ≤50 kg\u002Fm².\n2. The subject is aged ≥18 years.\n3. Failed previous conservative weight loss alternatives (e.g., supervised diet, exercise, and behavior modification programs).\n4. Willing to avoid the use of medical devices, medications, or other substances for weight loss purposes during the study period.\n5. Willing to avoid the use of nonsteroidal anti-inflammatory drugs (NSAIDs) during the study period, including aspirin, diclofenac, ibuprofen, naproxen, or other known gastric-irritating drugs.\n6. Able to take proton pump inhibitors (PPIs), antiemetics, and other medications as prescribed by the researcher.\n7. Capable of walking completely independently, with no severe chronic orthopedic diseases.\n8. Willing to undergo gastroscopy.\n9. Voluntarily participate in the trial, sign the informed consent form, and be willing to comply with study requirements, including follow-ups.\n\nExclusion Criteria:\n\n1. Prior surgery involving the esophagus, stomach, and duodenum.\n2. Prior bariatric surgery or intragastric medical devices for weight loss.\n3. A large hiatal hernia of \\> 5 cm or a hernia ≤ 5 cm associated with severe or intractable gastroesophageal reflux symptoms.\n4. Patients who have a history of gastrointestinal obstruction, adhesive peritonitis.\n5. Any active inflammatory or neoplastic disease of the gastrointestinal tract. among these, inflammatory diseases include esophagitis, gastric ulcer, duodenal ulcer, and specific types (e.g., Crohn's disease), while neoplastic diseases include cancer, and the doctor judges that such conditions may affect the use of Orbera365.\n6. Potential upper gastrointestinal bleeding disorders, such as esophageal or gastric varices, congenital or acquired intestinal capillary ectasia, or other congenital gastrointestinal abnormalities, such as atresia or stenosis that precludes the usage for Orbera365.\n7. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and\u002For an endoscope that precludes the usage for Orbera365.\n8. Achalasia, symptoms suggestive of delayed gastric emptying, or presence of any other severe motility disorder that that may pose a safety risk during placement or removal of the device.\n9. Positive result in the Helicobacter pylori breath test (Patients who turn negative after regular treatment can participate in this clinical trial).\n10. History or symptoms of uncontrolled or unstable thyroid disease.\n11. Abnormal coagulation with an INR \\> 1.5 that cannot be corrected (as judged by a physician) or requiring continuous full anticoagulant therapy, and\u002For the presence of any underlying disease associated with a high risk of bleeding.\n12. Hepatic insufficiency or liver cirrhosis, including: acute liver failure, advanced liver cirrhosis with encephalopathy, muscle atrophy, and generalized edema. severe esophageal varices with red signs and gastric varices. severe portal hypertensive gastropathy with or without gastric antral vascular ectasia.\n13. Anemia: For females, hemoglobin (Hgb) \\\u003C 110 g\u002FL. for males, hemoglobin (Hgb) \\\u003C 120 g\u002FL.\n14. Patients with known or suspected allergic reactions to the materials contained in Orbera365.\n15. Any other physical conditions that do not allow for elective endoscopy, such as poor overall health or a history and\u002For symptoms of severe kidney, liver, heart, and\u002For lung diseases. severe or uncontrolled mental illnesses or abnormalities that may affect the patient's ability to understand or comply with follow-up visits and the removal of the device 12 months later.\n16. Patients who are unable or unwilling to take the prescribed proton pump inhibitor medications during the device placement period.\n17. Patients who are unwilling to avoid any reconstructive and\u002For plastic surgeries that may affect weight during the study period, such as mammoplasty and liposuction.\n18. Patients who are unwilling to participate in the established medical supervision diet and behavior modification program and undergo regular medical follow-ups.\n19. Patients who are receiving treatment with anticoagulants, antiplatelet drugs, immunosuppressants, non-steroidal anti-inflammatory drugs (NSAIDs), or other drugs known to irritate the gastroduodenal mucosa or reduce gastrointestinal motility and\u002For are unwilling to discontinue such concomitant medications. prescription or over-the-counter weight loss drugs, drugs known to cause significant weight gain or loss (such as anesthetics, opioids, or benzodiazepines), insulin, antiepileptic drugs, antiarrhythmic drugs (such as amiodarone). other drugs that may cause weight changes, including drugs that can significantly increase weight (such as glucocorticoids, insulin secretagogues, thiazolidinediones, atypical antipsychotics, sodium valproate, lamotrigine, antidepressants, etc.), and drugs that can significantly reduce weight (such as glucagon-like peptide-1 receptor agonists, α-glucosidase inhibitors, topiramate, fluoxetine, bupropion, zonisamide, etc.).\n20. Alcohol abuse and\u002For drug abuse.\n21. Evidence of untreated mental or eating disorders, such as major depressive disorder, schizophrenia, substance abuse, binge eating disorder, or bulimia nervosa.\n22. Poor overall health, presence of specific diseases, or situations that, in the judgment of the researcher during evaluation and\u002For device placement, may put the subject at significant risk, may confound the study results, may increase the risks associated with endoscopy and\u002For balloon placement, or may significantly interfere with the subject's participation in the study (for example, having acquired immunodeficiency syndrome or hepatitis C within the past 5 years).\n23. Pregnant, breastfeeding, or having the intention to become pregnant during the study period (for females of childbearing potential).\n24. Currently participating in a study of investigational drugs or devices, or having participated in such a study within 30 days before participating in this study.",{"count":83,"type":19},[127],"To demonstrate the safety and efficacy of Orbera365 in obese populations to support the registration of Orbera365.",[229],{"date":192,"type":30},{"date":251,"type":30},"2026-06-03",{"date":253,"type":19},"2028-12-31",{"name":36,"class":37},1,{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":255},"100574702","farapulse-pulsed-field-ablation-system-100574702","NCT06762717","FARAPULSE™ Pulsed Field Ablation System","Real World Data Collection in Chinese Population Treated With the FARAPULSE™ Pulsed Field Ablation System","Inclusion Criteria:\n\n1. Subjects intended to be treated with the FARAPULSE™ Pulsed Field Ablation system for cardiac tissue ablation, per physician's medical judgement, and as per hospitals' standard of care\n2. Subjects who are willing and capable of providing informed consent\n3. Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center\n4. Subjects whose age is 18 years or above.\n\nExclusion Criteria:\n\n1. Subjects with a current interatrial baffle or patch\n2. Subjects with a known or suspected atrial myxoma\n3. Subjects with a myocardial infarction within 14 days prior to enrollment\n4. Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA)\n5. Subjects who do not tolerate anticoagulation therapy\n6. Subjects with an active systemic infection \\*\n7. Subjects with a presence of atrial known thrombus \\*\n8. Subjects with a known inability to obtain vascular access\n9. Subjects who are pregnant or planning to be pregnant\n10. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible \u002F non-cardiac causes\n11. Subjects with any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty\n12. Subjects with a contraindication to an invasive electrophysiology procedure where insertion or manipulation of a catheter in the cardiac chambers is deemed unsafe per physician's medical judgement, such as, but not limited to, a recent previous cardiac surgery (e.g., ventriculotomy or atriotomy, CABG, PTCA\u002FPCI\u002Fcoronary stent procedure), recent previous unstable angina and\u002For in patients with congenital heart disease where the underlying abnormality increases the risk of the ablation (e.g., severe rotational anomalies of the heart or great vessels)\n13. Subjects with a life expectancy of ≤ 1 year per investigator's opinion\n14. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility.",{"count":264,"type":19},500,"To obtain real world data on the use of, and provide continued evidence on safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) system when used per hospitals' standard of care in Chinese population.",[267],"Paroxysmal AF",{"date":192,"type":30},{"date":270,"type":30},"2025-10-23",{"date":272,"type":19},"2029-12-31",{"name":36,"class":37},{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":125,"phases":284,"briefSummary":285,"conditions":286,"keywords":289,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":298},"100627106","evaluation-of-novel-waveforms-delivered-using-the-farapulse-pfa-system-100627106","NCT07444320","Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System","A Multicenter Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System in Patients With Atrial Fibrillation","IMPULSE-EVO","Inclusion Criteria:\n\n1. ≥ 18 years of age, or older if required by local law\n2. Persistent Atrial Fibrillation or Paroxysmal Atrial Fibrillation\n\n   1. Persistent AF Documented:\n\n      * Physician's note confirming the presence of persistent atrial fibrillation and the arrhythmia symptoms\n      * Within 180 days prior to Enrollment: A 24-hour continuous ECG recording confirming continuous AF OR Two (2) ECGs from any regulatory-cleared rhythm monitoring device showing continuous AF taken at least 7 days apart.\n\n      OR\n   2. Paroxysmal AF Documented:\n\n      * Physician's note confirming the presence of paroxysmal atrial fibrillation and the arrhythmia symptoms\n      * Within 180 days of the Enrollment Date, one (1) ECG from any regulatory-cleared rhythm monitoring device showing atrial Fibrillation (AF)\n3. Willing and capable of providing informed consent\n4. Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center\n\nExclusion Criteria:\n\n1. Atrial exclusions - any of the following atrial conditions:\n\n   1. Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter is not available, LA non-indexed volume \\> 100 mL. If both values are available, only the LA diameter will be used to confirm eligibility.\n   2. Any prior atrial endocardial, epicardial, or surgical ablation procedure for arrhythmia other than ablation for right-sided SVT or cavotricuspid isthmus ablation\n   3. Any prior atrial surgery\n   4. Current atrial myxoma\n   5. Current Left Atrial Thrombus\n   6. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)\n2. Cardiovascular Conditions - Any of the following cardiovascular conditions:\n\n   1. History of sustained ventricular tachycardia (VT) or any ventricular fibrillation (VF)\n   2. Atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible\u002Fnon-cardiac causes\n   3. Cardiac Devices and Implants:\n\n      * Current or anticipated pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization therapy devices.\n      * Interatrial baffle, patent foramen ovale, or atrial septal defect closure device or patch.\n      * Any Left Atrial Appendage Closure or Occlusion Device, except a WATCHMAN™ device implanted \\> 90 days before Enrollment\n   4. Valvular Disease - Presence of any of the following:\n\n      * Any prosthetic heart valve, ring or repair\n      * Moderate to severe mitral valve stenosis\n      * More than moderate mitral regurgitation (≥ 3+)\n      * Moderate to severe aortic stenosis\n   5. Cardiomyopathy - Hypertrophic cardiomyopathy\n   6. Access Issues - Any IVC filter, known inability to obtain vascular access, or other contraindication to femoral access\n   7. Anticipated Cardiac Surgery - Awaiting cardiac transplantation or other planned cardiac surgery within the next 12 months\n3. Congenital Conditions - Any of the following congenital conditions:\n\n   a. Congenital heart disease with any clinically significant residual anatomic or conduction abnormality\n4. Baseline Conditions - Any of the following conditions at Baseline:\n\n   1. Heart failure - Heart failure associated with NYHA Class III or IV\n   2. Ejection Fraction - Most recent documented LVEF \\\u003C 40% within the previous 12 months\n   3. Obesity: Body Mass Index (BMI) \\> 45.0 kg\u002Fm\\^2\n   4. Hematologic Condition: Known coagulopathy or bleeding disorder\n   5. Anticoagulation Contraindication: Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation\n   6. Pregnancy - Women who are confirmed to be pregnant or lactating at the time of the ablation procedure\n   7. Pulmonary Disease - Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen\n   8. Malignancy - Active malignancy (other than non-melanoma skin cancers)\n   9. Gastrointestinal - Clinically significant gastrointestinal problems involving the esophagus or stomach, including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration\n   10. Infection - Known active systemic infection\n   11. Sleep Apnea - Untreated diagnosed obstructive sleep apnea with apnea-hypopnea index classification of severe (\\> 30 events per hour) as per the guidelines\n   12. Life Expectancy - Predicted life expectancy of less than one (1) year per investigator medical judgment\n   13. Concurrent Enrollment - Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility\n5. Any of the following events within 90 days of the Consent Date:\n\n   1. Coronary disease - Myocardial infarction (MI), unstable angina or coronary intervention\n   2. Pericardium - Pericarditis or symptomatic pericardial effusion\n   3. GI Bleeding - Gastrointestinal bleeding\n   4. Cardiac Surgery - Any cardiac surgery\n   5. Neurovascular Event - Stroke, TIA, or intracranial bleeding\n   6. Thromboembolism - Any active non-neurologic thrombus and\u002For thromboembolic event\n   7. Carotid Intervention - Carotid stenting or endarterectomy\n   8. Diabetes - Uncontrolled diabetes mellitus or a recorded HgbA1c \\> 8.0%\n6. Medical History - Any of the following conditions in the Medical History\n\n   1. Transplantation - Solid organ or hematologic transplant, or currently being evaluated for a transplant\n   2. Diaphragmatic Abnormality - Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis\n   3. Coronary Disease - Any documented history of Prinzmetal angina or severe non-revascularizable coronary disease\n   4. Renal Disease - Renal insufficiency if an estimated glomerular filtration rate (eGFR) is \\\u003C 30 mL\u002Fmin\u002F1.73 m2, or with any history of renal dialysis or renal transplant\n   5. General Medical Conditions - Any other general health conditions that, in the investigator's medical opinion, would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation.",{"count":283,"type":19},200,[127],"This is a multicenter, prospective, single-arm, feasibility study to evaluate the safety and effectiveness of the waveforms being delivered using the FARAPULSE PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF).",[287,288],"Paroxysmal Atrial Fibrillation","Persistent Atrial Fibrillation",[290],"Pulsed Field Ablation","2026-06-26",{"date":192,"type":30},{"date":294,"type":30},"2026-02-12",{"date":296,"type":19},"2028-02",{"name":36,"class":37},4,{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":125,"phases":308,"briefSummary":309,"conditions":310,"keywords":315,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":326},"100619784","option-emea-clinical-trial-100619784","NCT07349121","OPTION-EMEA Clinical Trial","Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation - Europe, Middle East and Africa [OPTION-EMEA]","OPTION-EMEA","Inclusion Criteria:\n\n1. Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN FLX™ Pro or WATCHMAN FLX™ for LAAC, per physician medical judgement and as per hospitals' standard of care.\n2. Subjects who are willing and able to provide informed consent.\n3. Subjects who are willing and able to participate in all testing associated with this clinical study at an approved investigational center.\n4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.\n\nExclusion Criteria:\n\n1. Subjects who underwent prior AF ablation procedure.\n2. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible \u002F non-cardiac causes.\n3. Already surgically closed or otherwise excluded LAA.\n4. The LAA anatomy does not accommodate a Closure Device.\n5. Known or suspected atrial myxoma.\n6. Presence of intracardiac thrombus\\*.\n7. Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an atrial septal defect (ASD) \u002F patent foramen ovale (PFO) device.\n8. Subjects with a presence of a mechanical valve prosthesis in any position.\n9. Subjects with a myocardial infarction within 90 days prior to enrollment.\n10. Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within 90 days prior to enrollment.\n11. Any planned electrical cardioversion within 30 days following LAAC device implant.\n12. Subjects with a known inability to obtain vascular access.\n13. Subjects with any contraindication to percutaneous catheterization procedure (e.g., patient size does not accommodate required catheters, ventriculotomy or atriotomy) or congenital abnormalities (severe rotational anomalies of the heart or great vessels) are present.\n14. Subjects with any active conditions (e.g. infection, bleeding disorder, unstable angina).\n15. Subjects with any contraindications to short term use of anticoagulation therapy for conditions different from atrial fibrillation.\n16. Subjects who are pregnant or planning to be pregnant.\n17. Subjects with a life expectancy of ≤ 1 year per investigator's opinion.\n18. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be reviewed by the sponsor to determine eligibility.",{"count":264,"type":19},[127],"The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with a WATCHMAN FLX™ Pro or WATCHMAN FLX device during one interventional case.\n\nThe study will include patients that are clinically indicated for atrial fibrillation (AF) ablation using the FARAPULSE PFA System and for left atrial appendage closure (LAAC) treatment using a WATCHMAN FLX Pro or WATCHMAN FLX device as part of the patient's standard of care determined by their doctor's medical judgement.",[184,311,312,290,313,314],"Stroke Prevention in Patients With Atrial Fibrillation","Left Atrial Appendage Closure","Atrial Fibrillation Ablation Procedure","Concomitant Procedures",[316,187,317,318,319],"WATCHMAN","Concomitant","PFA","LAAC",{"date":192,"type":30},{"date":322,"type":30},"2026-06-18",{"date":324,"type":19},"2029-12",{"name":36,"class":37},3,{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":125,"phases":337,"briefSummary":338,"conditions":339,"keywords":340,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":357},"100572612","repeat-ablation-of-persistent-atrial-fibrillation-including-mitral-isthmus-catheter-ablation-with-the-farapulse-pulsed-field-ablation-system-100572612","NCT06735534","Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System","The ReMATCH Study is a Prospective, Single Arm, Open Label, Multi-center, Study Utilizing the FARAPULSE PFA System, Including the FARAWAVE and FARAPOINT PFA Catheters","ReMATCH","Inclusion Criteria:\n\n* ≥ 18 years of age, or older if required by local law\n* Single previous endocardial AF ablation procedure for PAF or PersAF that minimally included pulmonary vein isolation\n* Documented (physician's note) diagnosis of PersAF either prior to the subject's Index Procedure OR development of PersAF after the Index Procedure.\n* Documented evidence of symptomatic AF recurrence at least 60 days after the subject's Index Procedure, captured by any regulatory cleared rhythm monitoring device.\n\nOR\n\n* If diagnosed with PersAF prior to the Index Procedure, documented recurrence of symptomatic AF or atypical AFL at least 60 days after the Index Procedure, captured by any regulatory cleared rhythm monitoring device.\n* Willing and capable of providing informed consent\n* Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center\n\nExclusion Criteria:\n\n1. Atrial exclusions - Any of the following atrial conditions:\n\n   a. Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non-indexed volume \\>100 ml (physician note or imaging) b. Current atrial myxoma c. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible) d. Current left atrial thrombus\n2. Cardiovascular exclusions - Any of the following CV conditions:\n\n   1. History of sustained ventricular tachycardia or any ventricular fibrillation\n   2. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible \u002F non-cardiac causes\n   3. Current or anticipated implantable cardioverter defibrillator, cardiac resynchronization therapy devices, or implantable loop recorders, other than LUX-Dx. Patients with a pacemaker are permitted; however, pacemaker-dependent patients are excluded.\n\n      Prior interatrial baffle, atrial septal patch, atrial septal defect closure device, patent foramen ovale occluder Left atrial appendage closure devices are excluded, with the exception of WATCHMAN. WATCHMAN is excluded if implanted within 90 days of enrollment\n   4. Presence of any of the following:\n\n      • Any prosthetic heart valve, ring or repair\n\n      • Moderate to severe mitral valve stenosis\n\n      • More than moderate mitral regurgitation (\\>3+)\n      * Moderate to severe aortic stenosis\n   5. Hypertrophic cardiomyopathy\n   6. Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access\n   7. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months\n   8. Severe right ventricular dysfunction with documented echocardiography and\u002For hemodynamic data.\n3. Any of the following conditions at baseline:\n\n   1. Heart failure associated with NYHA Class III or IV\n   2. Documented LVEF \\\u003C 40% as documented within the previous 12 months\n   3. Uncontrolled hypertension (SBP \\> 160 mmHg or DBP \\> 95 mmHg on two (2) BP measurements at baseline assessment not attributable to white coat syndrome per Investigator opinion\n   4. Body Mass Index (BMI) \\>45.0\n   5. CHA2DS2-VASc score ≥5\n4. Any of the following events within 90 Days of the Consent Date:\n\n   1. Coronary disease: Myocardial infarction (MI), unstable or Prinzmetal angina or coronary intervention within 90 days of consent or any documented history of severe non-revascularize coronary disease\n   2. Cardiac surgery: Any cardiac surgery\n   3. Heart failure hospitalization: Heart failure hospitalization\n   4. Pericardium: Pericarditis or symptomatic pericardial effusion\n   5. GI bleeding: Gastrointestinal bleeding\n   6. Neurovascular event: Stroke, TIA, or intracranial bleeding\n   7. Thromboembolism: Any active non-neurologic thrombus and\u002For thromboembolic event\n   8. Carotid intervention: Carotid stenting or endarterectomy\n   9. Diabetes: Uncontrolled diabetes mellitus or a recorded HgbA1c \\> 8.0%\n5. Any of the following congenital conditions:\n\n   1. Congenital heart disease: Congenital heart disease with any clinically significant residual anatomic or conduction abnormality\n   2. Methemoglobinemia: History of known congenital methemoglobinemia\n   3. G6PD deficiency: History of known G6PD deficiency\n6. Any of the following conditions:\n\n   1. Transplantation: Solid organ or hematologic transplant, or currently being evaluated for a transplant\n   2. Diaphragmatic abnormality: Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis.\n\n   Pulmonary: Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen d. Renal: Renal insufficiency if an estimated glomerular filtration rate (eGFR) is \\\u003C 30 mL \u002F min \u002F 1.73 m2, or with any history of renal dialysis or renal transplant e. Malignancy: Active malignancy (other than squamous cell carcinoma) f. Gastrointestinal: Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration g. Infections: Active systemic infection h. Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure i. Nitroglycerin intolerance: Known allergic drug reaction to nitroglycerin (excluding hypotension) j. Hematologic condition: Known coagulopathy or bleeding disorder (e.g. von Willebrand disease, hemophilia) k. Contraindication to anticoagulation: Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation.\n\n   l. Pregnancy: Women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period m. General health conditions: Health conditions that, in the investigator's medical opinion, would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation.\n\n   n. LUX-Dx ICM intolerance: Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx ICM device o. Participation in another trial: Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility.\n\n   p. Life expectancy: Predicted life expectancy less than one (1) year",{"count":336,"type":19},376,[127],"The ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters.",[288],[341,342,343,344,345,346,347,348,349,350],"Pulsed Field Ablation (PFA))","Pulmonary Vein Isolation","Recurrent Arrhythmia","cavo-tricuspid isthmus (CTI)","CTI dependent flutter","Anti Arrhythmic Drugs (AAD)","Atrial Flutter","Atrial Tachycardia","Atrial fibrillation","Electrical cardioversion",{"date":192,"type":30},{"date":353,"type":30},"2025-06-03",{"date":355,"type":19},"2028-01",{"name":36,"class":37},41,{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":125,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":298},"100555320","feasibility-study-of-the-faraflex-mapping-and-pfa-system-100555320","NCT06510556","Feasibility Study of the FARAFLEX Mapping and PFA System","Feasibility Study of the FARAFLEX Mapping and Pulsed Field Ablation (PFA) System in the Treatment of Persistent Atrial Fibrillation","ELEVATE-PF","Inclusion Criteria:\n\n1. Age ≥ 18 years of age, or older if required by local law\n2. Symptomatic, documented, Persistent AF or Paroxysmal AF\n3. Willing and capable of providing informed consent\n4. Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center\n\nExclusion Criteria:\n\n1. Atrial exclusions - Any of the following atrial conditions:\n\n   * Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non indexed volume \\>100 ml (by MRI, CT or TTE report or physician note)\n   * Any prior atrial endocardial, epicardial or surgical ablation procedure for atrial arrhythmia other than ablation for right sided SVT\n   * Current atrial myxoma\n   * Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)\n   * Current left atrial thrombus\n2. Cardiovascular exclusions - Any of the following CV conditions:\n\n   * History of sustained ventricular tachycardia or any ventricular fibrillation AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible \u002F non-cardiac causes\n   * Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, interatrial baffle, closure device, patch, or patent foramen ovale occluder, LA appendage closure, device or occlusion\n   * Valvular disease that is symptomatic or is the cause of heart failure.\n   * Hypertrophic cardiomyopathy\n   * Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty\n   * Known inability to obtain vascular access or other contraindication to femoral access\n   * Rheumatic heart disease\n   * Awaiting cardiac transplantation or other cardiac surgery within the next 12 months\n   * Known allergic drug reaction to nitroglycerin1\n   * Known severe non-revascularizable coronary disease\n   * Pre-existing right coronary artery stent and left circumflex artery\n3. Any of the following conditions at baseline:\n\n   * Heart failure associated with NYHA Class IV\n   * LVEF \\\u003C 40%\n   * Uncontrolled hypertension (SBP \\> 160 mmHg or DBP \\> 95 mmHg on two (2) BP measurements at baseline assessment\n   * Severe right ventricular dysfunction with documented echocardiography and\u002For hemodynamic data.\n4. Any of the following events within 90 Days of the Consent Date:\n\n   * Myocardial infarction (MI), unstable or Prinzmetal angina or coronary intervention\n   * Any cardiac surgery\n   * Heart failure hospitalization\n   * Pericarditis or symptomatic pericardial effusion\n   * Gastrointestinal bleeding\n   * Stroke, TIA, or intracranial bleeding\n   * Any non-neurologic thromboembolic event\n   * Carotid stenting or endarterectomy\n5. Known coagulopathy disorder (e.g. von Willibrand's disease, hemophilia)\n6. Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation.\n7. Women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period\n8. Any of the following health conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation, including but not limited to:\n\n   * Body Mass Index (BMI) \\> 42.0\n   * Solid organ or hematologic transplant, or currently being evaluated for a transplant\n   * Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis\n   * Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen\n   * Renal insufficiency if an estimated glomerular filtration rate (eGFR) is \\\u003C 30 mL \u002F min \u002F 1.73 m2, or with any history of renal dialysis or renal transplant\n   * Active malignancy at enrollment (other than squamous cell carcinoma)\n   * Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration\n   * Active systemic infection\n   * Untreated diagnosed obstructive sleep apnea with apnea hypopnea index classification of severe (\\>30 pauses per hour)\n   * Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure\n\n10\\. Predicted life expectancy less than one (1) year 11. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility 12. Any of the following congenital conditions:\n\n* Congenital heart disease with any clinically significant residual anatomic or conduction abnormality\n* History of known congenital methemoglobinemia\n* History of known G6PD deficiency\n\nELEVATE-COR (additional) Eligibility Criteria:\n\nInclusion Criteria:\n\n1. Meets all inclusion criteria according to the ELEVATE-PF Protocol\n2. Planned for adjunctive CTI ablation\n3. Willing and capable of participating in all assessments and testing associated with this sub-study protocol.\n\nExclusion Criteria:\n\n1. Meets any of the exclusion criteria outlined in the ELEVATE-PF Protocol\n2. Pre-existing right coronary artery stent and\u002For left circumflex artery stent\n3. Known severe non-revascularizable coronary disease\n4. Moderate to severe coronary artery disease that in the opinion of the investigator would put the patient at increased risk\n5. Known calcium score ≥1000\n6. Renal insufficiency if an estimated glomerular filtration rate (eGFR) is \\\u003C 30 mL \u002F min \u002F 1.73 m2, or with any history of renal dialysis or renal transplant\n7. Contraindication to IVUS\n8. Body Mass Index (BMI) \\> 35.0",{"count":367,"type":19},250,[127],"The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF) or symptomatic Paroxysmal Atrial Fibrillation (PAF).",[371,288,267],"Atrial Fibrillation",{"date":190,"type":30},{"date":374,"type":30},"2025-02-17",{"date":376,"type":19},"2027-09-15",{"name":36,"class":37},{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":125,"phases":388,"briefSummary":389,"conditions":390,"keywords":392,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":255},"100639755","evaluation-of-the-faraflex-mapping-and-pulsed-field-ablation-system-in-subjects-with-atrial-fibrillation-100639755","NCT07575269","Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation","Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation - A Global Prospective Single Arm Study","FARADIGM","Inclusion Criteria:\n\n1. At least 18 years old (or older if required by local law)\n2. Symptomatic, documented, drug-refractory paroxysmal or persistent atrial fibrillation (AF).\n3. Willing and capable of providing written informed consent\n4. Willing and able to comply with all follow-up assessments and study procedures at an approved investigational site\n\nExclusion Criteria:\n\n1. Any of the following atrial conditions:\n\n   1. Left atrial anteroposterior diameter of at least 5.5 cm, or if not available, non-indexed volume greater than 100 mL\n   2. Any prior atrial endocardial, epicardial, or surgical ablation for atrial arrhythmia (excluding right-sided Supraventricular Tachycardia (SVT) or Cavo-Tricuspid Isthmus (CTI)-dependent flutter)\n   3. Any prior atrial surgery\n   4. Current atrial myxoma\n   5. Pulmonary vein abnormality, stenosis, or prior stenting (common and middle pulmonary veins allowed)\n   6. Current left atrial thrombus\n2. Any of the following cardiovascular conditions:\n\n   1. History of sustained ventricular tachycardia or ventricular fibrillation\n   2. Atrial fibrillation secondary to reversible or non-cardiac causes (e.g., electrolyte imbalance, thyroid disease, alcohol)\n   3. Presence of any of the following cardiac devices or implants:\n\n      * Current or anticipated pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy device\n      * Current implantable loop recorder other than LUX-Dx\n      * Prior interatrial baffle or septal closure device\u002Fpatch (Patent Foramen Ovale (PFO)or Atrial Septal Defect (ASD))\n      * Left atrial appendage closure or occlusion device\n   4. Clinically significant valvular disease, including:\n\n      * Any cardiac valve prosthesis, ring, repair, or clip\n      * Moderate to severe mitral stenosis\n      * Moderate to severe aortic stenosis\n      * Severe mitral regurgitation\n      * Severe tricuspid regurgitation\n   5. Hypertrophic or amyloid cardiomyopathy\n   6. Presence of Inferior Vena Cava (IVC) filter, inability to obtain vascular access, or contraindication to femoral access\n   7. Awaiting cardiac transplantation or other cardiac surgery within 12 months (left atrial appendage closure\u002Focclusion procedures allowed no less than (≥) 60 days after index procedure)\n   8. Severe right ventricular dysfunction per investigator assessment\n3. Any of the following congenital conditions:\n\n   1. Congenital heart disease with clinically significant residual anatomic or conduction abnormalities, or channelopathies\n   2. Known congenital methemoglobinemia\n   3. Known G6PD deficiency\n4. Any of the following medical history conditions:\n\n   1. Solid organ or hematologic transplant, or under evaluation for transplant\n   2. History or current evidence of hemi-diaphragmatic paralysis or paresis\n   3. Prinzmetal angina or severe non-revascularizable coronary disease\n   4. Known coagulopathy or bleeding disorder\n   5. Renal insufficiency, history of dialysis, or renal transplant\n   6. Known allergic reaction to nitroglycerin (excluding hypotension)\n   7. Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure\n   8. Active spinal cord stimulator\n5. Any of the following baseline conditions:\n\n   1. NYHA Class III or IV heart failure\n   2. Left ventricular ejection fraction (LVEF) less than 40% within 12 months\n   3. CHA2DS2-VASc score greater than or equal to 5\n   4. Body mass index (BMI) greater than 45.0\n   5. Contraindication to or unwillingness to use systemic anticoagulation peri-procedurally\n   6. Pregnant or lactating at time of procedure\n   7. Severe lung disease, pulmonary hypertension, or oxygen-dependent lung disease\n   8. Active malignancy (excluding squamous cell carcinoma)\n   9. Clinically significant gastrointestinal disease (e.g., severe or erosive esophagitis, uncontrolled reflux, gastroparesis, esophageal candidiasis, active gastroduodenal ulceration)\n   10. Known Active systemic infection\n   11. Life expectancy of less than 1 year\n   12. Concurrent enrollment in another investigational study or registry that may interfere with this study (exceptions include mandatory governmental registries or purely observational registries with sponsor approval)\n6. Any of the following events within 90 days prior to consent:\n\n   1. Myocardial infarction, unstable angina, or coronary intervention\n   2. Pericarditis or symptomatic pericardial effusion\n   3. Gastrointestinal bleeding\n   4. Cardiac surgery\n   5. Stroke, Transient Ischemic Attack (TIA), or intracranial bleeding\n   6. Any active non-neurologic thrombus and\u002For thromboembolic event\n   7. Carotid stenting or endarterectomy\n   8. Heart failure hospitalization\n   9. Uncontrolled diabetes mellitus or HbA1c greater than 8.0%\n7. Other conditions:\n\n   1. Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted ICM from the LUX-Dx family of devices\n   2. Any medical condition that, in the investigator's opinion, would interfere with study participation, increase risk, or affect data interpretation",{"count":387,"type":19},571,[127],"The goal of this clinical trial is to learn if the FARAFLEX™ Mapping and pulsed field ablation (PFA) System can safely and effectively treat symptomatic, drug-refractory Paroxysmal atrial fibrillation (PAF) and Persistent atrial fibrillation (PersAF). The main question it aims to answer is:\n\nIs the FARAFLEX Mapping and PFA System a safe and effective treatment for patients?\n\nParticipants will undergo an ablation procedure using the FARAFLEX Mapping and PFA System.",[391,288],"Paroxysmal Atrial Fibrillation (PAF)",[393],"pulsed field ablation","2026-06-25",{"date":190,"type":30},{"date":397,"type":19},"2026-06-12",{"date":399,"type":19},"2030-01-01",{"name":36,"class":37},{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":408,"targetDuration":410,"studyType":20,"phases":4,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":230,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":4},"100628177","a-prospective-multicenter-single-arm-registry-of-enroute-nps-in-conjunction-with-carotid-wallstent-in-chinese-population-100628177","NCT07458243","A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population","ASCENT-C","Inclusion Criteria:\n\n* 1\\. Patients must meet one of the following criteria regarding neurological symptom status and degree of stenosis: Symptomatic: Stenosis must be \\>50% as determined by an angiogram (CTA\u002FMRA or catheter angiogram prior to the index procedure) and the patient has a history of stroke (minor or non-disabling; NIHSS ≤4 or mRS ≤2), TIA and\u002For amaurosis fugax within 180 days of the procedure ipsilateral to the carotid artery to be stented.\n\nOR Asymptomatic: Stenosis must be ≥70% as determined by angiogram (CTA\u002FMRA or catheter angiogram prior to the index procedure) without any neurological symptoms within the prior 180 days.\n\n2\\. Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and Carotid WALLSTENT Endoprosthesis (refer to IFU for requirements).\n\n3\\. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).\n\n4\\. Patient is ≥18 years of age. 5. Patient understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Institutional Review Board\u002FEthics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study.\n\n6\\. Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.\n\nExclusion Criteria:\n\n* 1\\. Patient has an alternative source of cerebral embolus, including but not limited to:\n\n  1. Patient has chronic atrial fibrillation.\n  2. Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.\n  3. Knowledge of any cardiac sources of emboli. (including but not limited to left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma).\n  4. Recently (\\\u003C60 days) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram.\n  5. Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by angiography or CTA\u002FMRA ≤ 6 months prior to index procedure) greater in severity than the lesion to be treated, cerebral aneurysm \\> 5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings.\n\n     2\\. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, or has had a recent (\\\u003C7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure.\n\n     3\\. Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.\n\n     4\\. Patient with a history of major stroke attributable to either carotid artery (CVA or retinal embolus) with major neurological deficit (NIHSS ≥ 5 OR mRS ≥ 3) likely to confound study endpoints within 1 month of index procedure.\n\n     5\\. Patient has an intracranial tumor. 6. Patient has an evolving stroke. 7. Patient has neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke, including but not limited to: moderate to severe dementia, partial or secondarily generalized seizures, complicated or classic migraine, tumor or other space-occupying brain lesions, subdural hematoma, cerebral contusion or other post-traumatic lesions, intracranial infection, demyelinating disease, or intracranial hemorrhage).\n\n     8\\. Patient has had a TIA or amaurosis fugax within 48 hrs prior to the procedure.\n\n     9\\. Patient has an isolated hemisphere. 10. Patient had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention.\n\n     11\\. Myocardial Infarction within 72 hours prior to the intervention. 12. Presence of a previous placed intravascular stent in target vessel or ipsilateral CCA or significant CCA inflow lesion.\n\n     13\\. Occlusion or \\[Thrombolysis In Myocardial Infarction Trial (TIMI 0)\\] \"string sign\" \\>1cm of the ipsilateral common or internal carotid artery.\n\n     14\\. An intraluminal filling defect (defined as an endoluminal lucency surrounded by contrast, seen in multiple angiographic projections, in the absence of angiographic evidence of calcification) whether or not it is associated with an ulcerated target lesion.\n\n     15\\. Ostium of Common Carotid Artery (CCA) requires revascularization. 16. Patient has an open stoma in the neck. 17. Female patients who are pregnant or may become pregnant. 18. Patient has history of intolerance or allergic reaction to any of the study medications or stent materials (refer to stent IFU), including aspirin (ASA), ticlopidine, clopidogrel (or other P2Y12 inhibitors) , statin or contrast media (that can't be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine or ASA and clopidogrel or ASA and alternative P2Y12 inhibitor (e.g. ticagrelor \\[Brilinta\\], prasugrel \\[Effient\\]).\n\n     19\\. Patient has a life expectancy \\\u003C1 year (for symptomatic group regardless of surgical risk designation), or \\\u003C3 years (for asymptomatic HSR group), or \\\u003C 5 years (for asymptomatic SSR group) without contingencies related to other medical, surgical, or interventional procedures as per the Wallaert Score (for asymptomatic patients) and patients with primary, recurrent or metastatic malignancy who do not have independent assessment of life expectancy performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.\n\n     20\\. Patient has an unresolved or uncorrected bleeding disorder, known bleeding diathesis or hypercoagulable state.",{"count":409,"type":19},60,"1 Month","The study is a prospective, non-randomized, single-arm, multi-center registry to confirm the safe delivery of the Carotid WALLSTENT Endoprosthesis when used with the ENROUTE® Transcarotid Neuroprotection System in the Chinese population",[413],"Carotid Artery Stenosis",{"date":190,"type":30},{"date":416,"type":19},"2026-10-31",{"date":418,"type":19},"2027-09-30",{"name":36,"class":37},{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":427,"enrollmentInfo":428,"targetDuration":4,"studyType":125,"phases":430,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":230,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":436,"leadSponsor":438,"locationsCount":4},"100628175","combined-cm-and-stn-stimulation-for-motor-epilepsy-100628175","NCT07458217","Combined CM and STN Stimulation for Motor Epilepsy","CoSMos","Inclusion Criteria:\n\n* 1\\) 18-65 Years.\n* 2\\) Drug Resistant Epilepsy.\n* 3\\) Motor Epilepsy - defined as:\n\n  1. Epilepsy diagnosis meeting ILAE criteria\n  2. Motor Epilepsy defined as including one or more of:\n\n  i. Tonic, Clonic, or Tonic-Clonic activity; ii. Myoclonic Jerks; iii.Epileptic Spasms; iv.Focal Motor Seizures (identified primary lesion will be in motor functional area, such as primary motor cortex (BA4), pre-motor cortex (BA6), Central Posterior Gyrus (BA1-3), or other motor region); v.Motor activity not secondary to non-motor seizure. c.Clinical or Electrographic corroboration of at least one of: i.Video-EEG confirmation of motor seizure semiology; ii.Interictal or ictal EEG findings consistent with epileptic motor network involvement; iii.Consistent clinical description by trained cliniciants.\n* 4\\) \\>3 Focal or Generalized seizures \u002F month with an inter-seizure interval no great than 30 days.\n* 5\\) Subject or caregiver is able to provide epileptic seizure record within 90 days prior to the surgery.\n* 6\\) Voluntarily participate in the trial, sign the informed consent form, and be willing to comply with study requirements, including follow-ups.\n\nExclusion Criteria:\n\n* 1\\) Non Motor Epilepsy.\n* 2\\) Previous diagnosis of psychogenic\u002Fnon-epileptic seizures.\n* 3\\) Brain lesion resection or ablation surgery performed less than 6 months.\n* 4\\) Implanted Vagus nerve stimulation (VNS) or responsive neurostimulation (RNS) devices recommended neither stimulation off the device at least 6 months nor remove the device.\n* 5\\) Pregnant, breastfeeding, or having the intention to become pregnant during the study period (for females of childbearing potential).","65 Years",{"count":429,"type":19},10,[127],"This self-crossover, randomized controlled, pilot study aims to collect clinical data of bilateral stimulation of subthalamic nucleus (STN) combined with centromedian (CM) thalamus deep brain stimulation (DBS) for drug resistant epilepsy with motor symptom in adults.",[433],"Motor Epilepsy",{"date":190,"type":30},{"date":416,"type":19},{"date":437,"type":19},"2028-05-31",{"name":36,"class":37},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":447,"targetDuration":449,"studyType":20,"phases":4,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":459},"100425721","boston-scientific-rhythm-management-registry-socrates-100425721","NCT04823663","BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)","BoStOn SCientific Rhythm MAnagemenT REgiStry","SOCRATES","Inclusion Criteria:\n\n1. Subject is willing and capable of providing informed consent and\u002For to give approval to collect\u002Fstore\u002Fprocess personal health information by the sponsor or such consent\u002Fapproval is provided by a legally designated representative, if required by local law or regulation.\n2. Subject is (one criterion must be fulfilled) a. prospectively scheduled for a procedure involving i. use of a BSC EP Ablation product or BSC Capital Equipment product or ii. a BSC CRM product implant or b. retrospectively enrolled no more than 10 days after the index procedure and all data necessary for appropriate reporting of all past visits is available and complete including i. the procedure where being diagnosed or treated with at least 3 separate BSC EP Ablation products\u002Fcomponents or BSC Capital Equipment products\u002Fcomponents or ii. the BSC CRM product implant.\n\nExclusion Criteria:\n\n1. Subject is foreseen not to be followed at the enrolling center for at least 1 year after an implant procedure (CRM) or at least 1 month (EP).\n2. Subject is receiving diagnosis or therapy by means of any product, that is not approved for commercial use at the time of implant\u002Fprocedure.",{"count":448,"type":19},12500,"10 Years","SOCRATES is part of Boston Scientific's (BSC) Post-market surveillance system. The implementation of such systems is mandatory per local regulations such as the Regulation '(EU) 2017\u002F745 of the European Parliament and of the Council of 5 April 2017 on medical devices' or short Medical Device Regulation (MDR). The SOCRATES design is therefore based on the BSC's commitment as well as external regulatory requirements to proactively and systematically gather, record and analyze relevant data on the quality, performance and safety of devices throughout their entire lifetime.",[452],"Cardiac Disease",{"date":190,"type":30},{"date":455,"type":30},"2021-03-31",{"date":457,"type":19},"2030-12-31",{"name":36,"class":37},26,{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":466,"targetDuration":94,"studyType":20,"phases":4,"briefSummary":468,"conditions":469,"keywords":471,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":480},"100613105","watchman-flx-pro-european-registry-100613105","NCT07262255","WATCHMAN FLX Pro European Registry","Inclusion Criteria:\n\n1. Subject is attempted to be treated with the WATCHMAN FLX™ Pro LAAC device.\n2. Subject has non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve) and is clinically indicated for a WATCHMAN FLX™ Pro LAAC device, per the Instructions for Use (IFU).\n3. Subject or legal representative who are willing and capable of providing informed consent.\n4. Subject is able and willing to return for required follow-up visits and examinations.\n5. Subject whose age is 18 years or above, or who is of legal age to give informed consent specific to state and national law.\n\nExclusion Criteria:\n\n1. Subject has a documented life expectancy of less than 12 months.\n2. Subject who is currently enrolled in another investigational study or registry except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments.\n3. Intracardiac thrombus is present.\n4. An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present.\n5. The LAA anatomy will not accommodate a Closure Device.\n6. Subject has a known hypersensitivity or contraindications according to IFU.\n7. Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study.",{"count":467,"type":19},1000,"The WATCHMAN FLX Pro European registry is intended to gather real world clinical data for patients undergoing left atrial appendage closure (LAAC) with the WATCHMAN FLX™ Pro device. In a subregistry with approximately 300 patients, it is intended to use the VersaCross Connect™ LAAC Access Solution.",[470,312],"Non-valvular Atrial Fibrillation (AF)",[319],"2026-06-23",{"date":474,"type":30},"2026-06-24",{"date":476,"type":30},"2025-12-17",{"date":478,"type":19},"2028-09",{"name":36,"class":37},14,{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":489,"targetDuration":490,"studyType":20,"phases":4,"briefSummary":491,"conditions":492,"keywords":494,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":115},"100597715","safety-and-effectiveness-of-orbera365-intragastric-balloon-system-100597715","NCT07062094","Safety and Effectiveness of Orbera365™ Intragastric Balloon System","Safety and Effectiveness of Orbera365™ Intragastric Balloon System: A Multi-Center, Prospective, Standard of Care Registry","Orbera365","Inclusion Criteria:\n\n1. Subject is ≥ 18 years of age\n2. Subject meets the indicated population for the device according to the Instructions for Use (IFU) including obese patients with the BMI of 30-50 kg\u002Fm2 for weight loss and patients with BMI 40 kg\u002Fm2 and above or a BMI of 35 kg\u002Fm2 with comorbidities before obesity or another surgery, unless contraindicated.\n3. Subject is able to read, understand, and sign a written Informed Consent Form to participate in the registry\n\nExclusion Criteria:\n\n1. Subject is planning on becoming pregnant during the one year following study device placement\n2. Subject will complete follow-up visits at a location that the treating physician does not practice\n3. Subjects who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.\n4. Current use or use within the three months before the baseline visit of over-the-counter or prescribed weight loss supplements\u002Fmedications.\n5. Subjects who have conditions that are contraindicated for Orbera365™ IGB System as per the IFU, including, but not limited to:\n\n   * The presence of more than one IGB at the same time.\n   * Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease\n   * Potential upper gastrointestinal bleeding conditions\n   * A large hiatal hernia of \\> 5cm or a hernia ≤ 5 cm associated with severe or intractable gastro- esophageal reflux symptoms\n   * A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and\u002For an endoscope\n   * Achalasia, symptoms suggestive of delayed gastric emptying, or presence of any other severe motility disorder that that may pose a safety risk during placement or removal of the device.\n   * Gastric Mass.\n   * Severe coagulopathy.\n   * Taking aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants and not under medical supervision.\n   * Prior surgery involving the esophagus, stomach, and duodenum or bariatric surgery",{"count":283,"type":19},"13 Months","This is a prospective, multi-center, standard of care registry offered to subjects in the EU only that have already agreed to receive the Orbera365™ Intragastric Balloon (IGB) System for weight loss. Subjects that agree to participate in the registry will have data reported associated with standard of care weight management visits during the time the device is implanted (in-dwell period), with an additional visit 30 days after the removal procedure.",[493],"Obesity",[487,495,493,496],"Intragastric Balloon","Orbera365™ IGB System",{"date":394,"type":30},{"date":499,"type":30},"2026-04-07",{"date":501,"type":19},"2028-05-01",{"name":36,"class":37},{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":507,"acronym":508,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":216},"100584833","five-plus-year-efficacy-of-endoscopic-sleeve-gastroplasty-esg-for-sustained-weight-loss-100584833","NCT06894498","Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss","LIGHT","Inclusion Criteria:\n\n* Subject is ≥ 18 years of age at the time of the ESG procedure\n* Subject with a BMI between 30 kg\u002Fm2 and 50 kg\u002Fm2, inclusive, at the time of the primary ESG procedure using Overstitch Endoscopic Suturing System\n* Subject completed follow-up 1-year from the ESG procedure for weight loss management\n* Subject completed or is eligible for follow-up 5-years from the ESG procedure for weight loss management (visit can be collected either retrospectively or prospectively)\n* Subject has returned for a minimum of one annual follow-up at the treating site for weight loss management annually between two and four years from the procedure.\n* Subject is willing to complete one prospective visit (5 year or 5+ year, as appropriate)\n* Subject is able to read, understand, and sign a written Informed Consent Form to participate in the study\n\nExclusion Criteria:\n\n* None",{"count":206,"type":19},"The objective of this study is to assess the long term weight loss and weight loss journey of patients who received an Endoscopic Sleeve Gastroplasty (ESG) 5 or more years prior to enrollment.",[513,229],"Obesity and Obesity-related Medical Conditions",{"date":394,"type":30},{"date":516,"type":30},"2026-03-31",{"date":518,"type":19},"2026-12",{"name":36,"class":37},{"id":521,"slug":4,"hasResults":12,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":522,"targetDuration":49,"studyType":20,"phases":4,"briefSummary":50,"conditions":523,"keywords":524,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":525,"startDateStruct":526,"completionDateStruct":527,"leadSponsor":528,"locationsCount":64},"100579666",{"count":48,"type":19},[52,53],[55,56,57],{"date":474,"type":30},{"date":60,"type":30},{"date":62,"type":19},{"name":36,"class":37},{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":539,"conditions":540,"keywords":542,"overallStatus":230,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":4},"100643894","a-post-approval-study-to-evaluate-safety-and-effectiveness-of-multicompartmental-dosimetry-planning-100643894","NCT07669727","A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.","A Post Approval Single-arm Study Evaluating Transarterial Radioembolization Treatment for Hepatocellular Carcinoma Using Multicompartment Dosimetry Planning","ADVANCE-MCD","Inclusion Criteria:\n\n* TheraSphere Microspheres treatment determined as the optimal therapy\n* Have unresectable solitary HCC\n* Treatment Naïve\n* ECOG 0 or 1\n* Adequate liver function\n* Adequate renal and marrow function\n* Negative pregnancy test and\u002For adequate contraception for the patient and his\u002Fher sexual partner\n\nExclusion Criteria:\n\n* Macrovascular invasion\n* Extrahepatic metastases\n* Previous or current ascites\u002Fencephalopathy\n* Previous liver radiation, TACE, or systemic therapy for the disease\n* History of organ allograft including bone marrow\n* Any significant comorbities or contraindications to TheraSphere",{"count":538,"type":19},140,"The purpose of this study is to assess the safety and effectiveness of treating a tumor using a different planning method called MCD for the FDA-Approved device, TheraSphere.\n\nTheraSphere Microspheres are microscopic radioactive glass spheres that deliver radiation therapy in the liver tissue where they are placed. This study investigates a procedure called multicompartment dosimetry (MCD). When using a multicompartment dosimetry approach, the doctor will look at images of the liver to see where there is tumor to determine where to treat. That area will be divided into \"compartments\" where the dose to tumor and the healthy liver are calculated separately. The goal of MCD is to give the tumor a higher radiation dose while protecting more of the healthy part of the liver.\n\nTraditional planning for the TheraSphere Microspheres procedure uses single compartment dosimetry (SCD) which treats the tumor and the healthy liver as one area so the dose is more evenly distributed and the dose to the tumor may be lower than with the MCD approach. The single compartment approach is standard and is well established however this research study is to see if giving TheraSphere Microspheres with an MCD planning method is safe and effective by evaluating the effect of radiation on the liver as well as how the tumor responds to higher doses",[541],"Hepatocellular Carcinoma (HCC)",[543,544,545,546],"Hepatocellular Carcinoma","TheraSphere","multicompartment dosimetry","Radioembolization","2026-06-22",{"date":394,"type":30},{"date":550,"type":19},"2026-08",{"date":552,"type":19},"2029-05",{"name":36,"class":37},{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":125,"phases":562,"briefSummary":563,"conditions":564,"keywords":4,"overallStatus":230,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":567,"startDateStruct":568,"completionDateStruct":569,"leadSponsor":571,"locationsCount":216},"100620137","a-study-on-the-acquisition-of-2d-ice-images-with-the-chorus-idx-system-in-subjects-undergoing-an-ablation-procedure-100620137","NCT07353710","A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure","SONAR-ICE","Inclusion Criteria:\n\n1. Subjects who are able and willing to provide written informed consent prior to any study procedure.\n2. Subjects who are planned for an ablation procedure for any atrial arrhythmia using any commercially available Boston Scientific Ablation System, per physician's judgement and hospitals' standard practice.\n3. Subjects who are willing and able to participate in all testing and assessments associated with this clinical study at an approved clinical investigation center.\n4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.\n\nExclusion Criteria:\n\n1. Any of the following cardiac implanted devices\n\n   * Any prosthetic mitral or tricuspid heart valve, such as ring, repairs or clips\n   * Atrial septal defect (ASD) occluders including interatrial baffle, closure device, patch, or patent foramen ovale or ASD occluder\n2. Subjects with contraindications related to the use of the CHORUS IDx™ System:\n\n   * Subjects with inadequate vascular access\n   * Subjects with active systemic infection\n   * Subjects with presence of a known intracardiac thrombus in the chamber of use\n3. Women who are confirmed to be pregnant or lactating at the time of the Index Procedure\n4. Presence of other medical conditions, that, in the investigator's opinion, could limit the subject's ability to participate in the study\n5. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility",{"count":283,"type":19},[127],"A first-in-human prospective data collection study including subjects who are planned to undergo an ablation procedure for any atrial arrhythmia as per medical judgement and the site's standard practice, represents the most viable means to collect human anatomy ICE images for the purpose of software development.",[565,566],"Atrial Arrhythmia","Intracardiac Echocardiography",{"date":472,"type":30},{"date":137,"type":19},{"date":570,"type":19},"2027-01-31",{"name":36,"class":37},""]