[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Abbott Medical Devices\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":654},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,47,77,100,131,160,195,218,240,253,278,302,331,361,386,416,460,478,504,524,546,562,582,608,631],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053980","comprehensive-left-atrial-appendage-occlusion-with-rhythm-restoration-100053980",false,"NCT07523620","Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration","CLEAR","Inclusion Criteria:\n\n* Subject must provide written informed consent prior to any clinical investigation-related procedure.\n* 18 years of age or older, or the age of legal consent\n* CHA2DS2-VASc score of ≥ 3 for women and ≥ 2 for men\n* Able to stop anticoagulation by 90 days post index procedure\n* Able to adhere to the protocol defined post-concomitant procedure pharmacologic regimen of OAC for at least 60 days followed by SAPT\n* Plans to undergo a catheter ablation procedure including PVI due to symptomatic, recurrent, drug-refractory PAF or PersAF\n* Documented symptomatic PAF or PersAF. Documentation requirements are as follows:\n\nParoxysmal:\n\n* Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 12 months prior to enrollment AND\n* One electrocardiographically documented PAF episode within 12 months prior to enrollment.\n\nPersistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by\n\n* Physician's note, AND either\n* 24-hour Holter within 180 days prior to enrollment, showing continuous AF, OR\n* Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:\n\n  * That are taken at least 7 days apart but less than 12 months apart\n  * If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent\u002Fenrollment\n  * The most recent electrocardiogram must be within 180 days of enrollment.\n\nNOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of continuous AF from another ECG device.\n\nExclusion Criteria:\n\n* Known contraindication or allergy to NOACs or aspirin, preventing use of the drugs post-procedure\n* Required to take P2Y12 platelet inhibitor after the study procedure (e.g., due to percutaneous coronary intervention)\n* Patients with heart prosthetic valves\n* Patient implanted with an inferior vena cava filter\n* Patients with left ventricular ejection fraction ≤30%\n* Patients with NYHA Class IV heart failure\n* Patients who have undergone any invasive intervention or surgery within 30 days prior to the index procedure (diagnostic catheterization is not within scope, however, percutaneous coronary intervention is within scope)\n* Patients who have experienced stroke or transient ischemic attack within 90 days prior to study procedure\n* Patients who have had previous attempt at LAA surgical or epicardial intervention (e.g., stapling, suturing, ligation, epicardial LAA management device)\n* Patients previously diagnosed long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)\n* Patients with arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures within 90 days prior to the study procedure\n* Patients unable to receive heparin or an acceptable alternative to achieve adequate intra-procedural anticoagulation\n* Patients with a stent, constriction, or stenosis in a pulmonary vein\n* Patients with severe mitral regurgitation (regurgitant volume ≥ 60 mL\u002Fbeat, regurgitant fraction ≥ 50%, and\u002For effective regurgitant orifice area ≥ 0.40cm2)\n* Patients with severe renal failure (estimated glomerular filtration rate \\\u003C30 ml\u002Fmin\u002F1.73m2) or on chronic dialysis\n* Patients with severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms\n* Patients with hypertrophic cardiomyopathy (maximal LV wall thickness ≥ 15 mm in the absence of abnormal loading conditions such as hypertension or aortic stenosis)","ALL","18 Years",{"count":20,"type":21},240,"ESTIMATED","INTERVENTIONAL",[24],"NA","The objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO.",[27,28,29],"Atrial Fibrillation (AF)","Paroxysmal AF","Persistent Atrial Fibrillation",[31,32,33,29],"Left Atrial Appendage","Atrial Fibrillation","Paroxysmal Atrial Fibrillation","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2026-03-31",{"date":42,"type":21},"2028-02-28",{"name":44,"class":45},"Abbott Medical Devices","INDUSTRY",16,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100640923","a-post-market-assessment-of-the-safety-and-performance-of-the-triclip-system-100640923","NCT07586995","A Post-Market Assessment of the Safety and Performance of the TriClip™ System","A Post-Market Assessment of the Safety and Performance of the TriClip™ System (TREAT TR)","TREAT TR","Inclusion Criteria:\n\n1. Subject is eligible to receive the TriClip System per the current approved indications for use and is intended to undergo the procedure.\n2. Subject, or their legally authorized representative, has provided written informed consent prior to study procedure.\n3. Subject agrees to attend follow-up assessments.\n4. Subject is ≥ 18 years of age (or legal age of consent) at time of consent.\n\nExclusion Criteria:\n\n1. Subject is participating in another clinical study that could impact the follow-up or results of this study.\n2. Subject has an existing TriClip implant\n3. Presence of other conditions or factors that, in the Investigator's opinion, could limit the subject's ability to participate in follow-up.",{"count":56,"type":21},1000,"OBSERVATIONAL","The objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved indications for use.",[60],"Tricuspid Regurgitation (TR)",[62,63,64,65,66,60,67],"Tricuspid Regurgitation","Tricuspid","Cardiovascular","Tricuspid Valve Insufficiency","ABT-CIP-10594","Transcatheter Edge-To-Edge Repair (TEER)","2026-06-30",{"date":70,"type":38},"2026-07-02",{"date":72,"type":21},"2026-06",{"date":74,"type":21},"2033-08",{"name":44,"class":45},4,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100625318","grid-explore-mapping-study-100625318","NCT07421076","Grid eXplore Mapping Study","Inclusion Criteria:\n\n1. Subject must provide written informed consent prior to any clinical investigation-related procedure.\n2. Subject is at least 18 years of age.\n3. Documented symptomatic paroxysmal AF, defined as:\n\n   * Physician's note indicating self-terminating AF AND\n   * Electrocardiographically documented AF NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device.\n4. Subject plans to undergo a cardiac electroanatomic mapping and ablation procedure to treat their paroxysmal AF.\n5. Able and willing to comply with all trial requirements including pre-procedure, post-procedure, and follow-up testing and requirements\n\nExclusion Criteria:\n\n1. Primary diagnosis or indication for treatment of persistent or long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)\n2. Known presence of cardiac thrombus.\n3. Known existing circumferential pericardial effusion \\>2 mm prior to catheter insertion.\n4. Presence of any condition that precludes appropriate vascular access\n5. Implanted intracardiac device within 30 days prior to the procedure\n6. Pregnant or nursing\n7. Patients who have had a ventriculotomy or atriotomy within 28 days prior to the procedure\n8. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days\n9. Stroke or TIA (transient ischemic attack) within the last 90 days\n10. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state\n11. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation\n12. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication\n13. Previous left atrial surgical procedure (including left atrial appendage (LAA) closure device)\n14. Severe mitral regurgitation (regurgitant volume ≥ 60 mL\u002Fbeat, regurgitant fraction ≥ 50%, and\u002For effective regurgitant orifice area ≥ 0.40cm2)\n15. Previous tricuspid or mitral valve replacement or repair\n16. Patients with prosthetic valves\n17. Patients with a myxoma\n18. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt\n19. Stent, constriction, or stenosis in a pulmonary vein\n20. Rheumatic heart disease\n21. Hypertrophic cardiomyopathy\n22. Active systemic infection\n23. Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms\n24. Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial without pre-approval from this study Sponsor\n25. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.\n26. Individuals without legal authority\n27. Individuals unable to read or write",{"count":84,"type":21},200,[24],"The purpose of the trial is to find out if the Grid X Mapping Catheter and EnSite X EP System with EnSite X Software v3.1.1, the devices that are being studied, are safe and effective in treating Chinese patients who have atrial fibrillation.\n\nParticipants will receive a procedure called catheter mapping and ablation to treat their abnormal heart rhythms and are required to complete 4 follow-up visits at 7 days, 3 months, 6 months and 12 months after the procedure for checkups and tests.",[88],"Paroxysmal Atrial Fibrillation (PAF)",[90],"Paroxysmal atrial fibrillation","2026-06-29",{"date":93,"type":38},"2026-07-01",{"date":95,"type":38},"2026-04-02",{"date":97,"type":21},"2027-10-31",{"name":44,"class":45},5,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":17,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100548625","treatment-resistant-depression-subcallosal-cingulate-network-dbs-transcend-100548625","NCT06423430","Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)","Treatment ResistAnt Depression Subcallosal CingulatE Network DBS","TRANSCEND","Inclusion Criteria:\n\n1. The patient must be diagnosed with non-psychotic unipolar Major Depressive Disorder.\n2. The patient must be in a major depressive episode for ≥12 months or have had at least 3 lifetime depressive episodes.\n3. The patient has tried and failed a minimum of four different types of antidepressant treatments as measured by a tool designed for this purpose.\n4. Depression medication and treatment regimen must be stable for a minimum of 4 weeks before the first baseline visit\n\nExclusion Criteria:\n\n1. Pregnant or those who plan to become pregnant during study\n2. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that could limit participation in the study or interfere with adherence to the study protocol.\n3. Current or lifetime history of psychotic features in any Major Depressive Episode.\n4. Has an intracranial Central Nervous System disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication.\n5. Significant acute suicide risk.\n6. Diagnosis of Substance Use Disorder or Alcohol Use Disorder without sustained remission (12 months or longer).\n7. Current and ongoing use of neurostimulation treatment that may interfere with DBS therapy\u002Fsystem.\n8. Treatment with another investigational device or investigational drugs.","22 Years","70 Years",{"count":111,"type":21},100,[24],"The goal of this clinical trial is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using Deep Brain Stimulation (DBS) as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) in adults.",[115],"Treatment Resistant Depression",[117,118,119,120,121,122],"DBS","Major Depressive Disorder","Bilateral Stimulation","Antidepressant Treatment","neurostimulation","ABT-CIP-10494","2026-06-25",{"date":91,"type":38},{"date":126,"type":38},"2024-09-11",{"date":128,"type":21},"2029-04",{"name":44,"class":45},24,{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":138,"studyType":57,"phases":4,"briefSummary":139,"conditions":140,"keywords":148,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},"100598298","abbott-cephea-mitral-valve-disease-registry-100598298","NCT07069673","Abbott Cephea Mitral Valve Disease Registry","Inclusion Criteria:\n\n1. Symptomatic mitral valve disease resulting in mitral regurgitation and\u002For severe mitral valve stenosis.\n2. New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV.\n3. In the judgement of the Site Heart Team, transcatheter therapy is deemed to be more appropriate than conventional mitral valve surgery, TMVR is more likely to provide an optimal result than TEER, and the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, and heart failure.\n4. Age 18 years or older at time of consent.\n5. The subject agrees to the study requirements, permits all follow-up data entry, and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.\n2. Subject is undergoing dialysis or experiencing chronic renal failure\n3. Subject has chronic lung disease requiring continuous home oxygen therapy or chronic outpatient oral steroid use\n4. Subjects with comorbidities that are likely to result in a life expectancy of less than 12 months.\n5. Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.",{"count":56,"type":21},"2 Years","The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease. Data collected from this registry are expected to improve our understanding of the impact of correcting symptomatic mitral valve disease on clinical outcomes in patients that could be candidates for Transcatheter Mitral Valve Replacement and may also inform future regulatory or reimbursement submission strategies for the Cephea Mitral Valve System.",[141,142,143,144,145,146,147],"Mitral Regurgitation","Mitral Stenosis","Mitral Valve Disease","Mitral Valve (MV) Regurgitation","Mitral Annulus Calcification","Mitral Valve Replacement","Transcatheter Valve Replacement",[143,149,150],"registry","Cephea Mitral Valve System","2026-06-18",{"date":153,"type":38},"2026-06-22",{"date":155,"type":38},"2025-08-13",{"date":157,"type":21},"2028-12",{"name":44,"class":45},23,{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":176,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},"100556522","trial-to-evaluate-safety-and-effectiveness-of-mechanical-circulatory-support-in-patients-with-advancing-heart-failure-100556522","NCT06526195","Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure","TEAM-HF","Inclusion Criteria:\n\n1. Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure\n2. LVEF ≤30% and Cardiac Index ≤ 2.5 L\u002Fmin\u002Fm²\n3. Limited functional status as demonstrated by 6MWT ≤ 350 m due to HF related reasons OR peak VO2 ≤ 14 mL\u002Fkg\u002Fmin (or \\\u003C50% of predicted peak VO2 value)\n4. NYHA Class IIIB or NYHA Class IV\n5. Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months\n6. Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant\n7. Subject is willing and able to be implanted with the HM3 LVAS if randomized to HM3 Group\n\nRandomization Criteria:\n\n1. Subject has been implanted with a CardioMEMS PA Sensor for at least 90 days.\n2. Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days.\n3. mean PAP ≥ 30 mmHg.\n4. The subject will not be randomized if they have any other factor that represents inordinate risk for either continued GDMT or LVAD implant.\n\nSingle Arm Registry Criteria:\n\n1. Subject has received a CardioMEMS PA Sensor implant following enrollment in the trial.\n2. Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days.\n3. mean PAP \\\u003C30 mmHg\n\nExclusion Criteria:\n\n1. Subject is \\\u003C 18 years of age at the time of informed consent.\n2. Dependent on IV inotrope in the last 30 days.\n3. Contra-indications to HM3 LVAS or CardioMEMS HF system.\n4. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy.\n5. Technical obstacles to LVAD or CardioMEMS implantation which pose an inordinately high surgical risk, in the judgment of the implanter.\n6. Existence of ongoing MCS.\n7. Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant.\n8. History of any solid organ transplant.\n9. Psychiatric disease\u002Fdisorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management.\n10. Presence of an active, uncontrolled infection.\n11. Complex congenital heart disease.\n12. Currently Pregnant or capable of becoming Pregnant and Unwilling to Use Contraception with LVAD.\n13. History of pulmonary embolism within 30 days prior to enrollment or history of recurrent (\\>1 episode) pulmonary embolism and\u002For deep vein thrombosis.\n14. Planned VAD or Bi-VAD support prior to enrollment.\n15. Presence of any one of the following risk factors for or indications of severe end organ dysfunction or failure:\n\n    1. An INR ≥ 2.0 not due to anticoagulation therapy\n    2. An eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 and nonresponsive to diuretic therapy or receiving chronic dialysis.\n    3. Biopsy proven liver cirrhosis.\n    4. Need for chronic renal replacement therapy.\n    5. History of severe chronic obstructive pulmonary disease (COPD) defined by Forced Expiratory Volume FEV1 \\\u003C 30% predicted.\n    6. History of cerebrovascular disease with significant (\\> 80%) uncorrected internal carotid stenosis.\n    7. Significant peripheral vascular disease (PVD) accompanied by ischemic rest pain or extremity ulceration.\n16. Any condition other than HF that could limit survival to less than 24 months.\n17. Participation in any other clinical investigation with an active treatment arm that is likely to confound study results or affect the study outcome.",{"count":168,"type":21},850,[24],"The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.",[172,173,174,175],"Heart Failure","Heart Diseases","Cardiovascular Diseases","Pulmonary Hypertension",[172,177,178,179,180,181,182,183,184,185],"Left Ventricular Assist Device (LVAD)","Guideline Directed Medical Therapy (GDMT)","Non-inotrope Dependent","Pulmonary Artery Pressure","Hemodynamic Monitoring","Medical Management","CardioMEMS","HeartMate 3 (HM3)","Ambulatory Advanced Heart Failure","2026-06-08",{"date":188,"type":38},"2026-06-10",{"date":190,"type":38},"2024-12-13",{"date":192,"type":21},"2032-09",{"name":44,"class":45},68,{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":216,"locationsCount":217},"100575454","viewflex-x-ice-first-in-human-study-100575454","NCT06772493","ViewFlex X ICE First-in-Human Study","ViewFlex X FIH","Inclusion Criteria:\n\nA patient will be eligible for clinical trial participation if they meet the following criteria:\n\n1. Able and willing to provide written informed consent prior to any clinical investigation-related procedure.\n2. Plans to undergo any EP procedure utilizing ICE\n3. At least 18 years of age\n\nExclusion Criteria:\n\nA patient will be excluded from enrollment in the study if they meet any of the following criteria:\n\n1. Subject is currently participating in another clinical trial with an active treatment arm or has participated in such a clinical trial within 30 days prior to enrollment that may interfere with this clinical trial without pre-approval from this study Sponsor\n2. Implanted mechanical mitral or tricuspid valve replacement\n3. Implanted intracardiac device within 30 days\n4. Pregnant or nursing\n5. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.",{"count":203,"type":21},500,"This prospective, acute, first-in-human, non-significant risk study is intended to evaluate a modified version of the ViewFlex X ICE Catheter, Sensor Enabled (ViewFlex X SE) and ViewMate Multi Ultrasound Console (VMM) ICE data integration with the EnSite X EP System (hereafter referred to as the ViewFlex X ICE System).",[206],"Cardiac Arrhythmias",[208,209],"Intracardiac Echocardiography","cardiac electrophysiology","2026-05-30",{"date":212,"type":38},"2026-06-02",{"date":214,"type":38},"2024-12-16",{"date":72,"type":21},{"name":44,"class":45},8,{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},"100620732","agilis-rf-tsp-early-feasibility-study-100620732","NCT07361445","Agilis RF TSP Early Feasibility Study","Agilis Radiofrequency Transseptal System Early Feasibility Study","Inclusion Criteria:\n\n* Is able and willing to provide written informed consent prior to any clinical investigation-related procedure\n* Plans to undergo an ablation procedure in LA, LV or concomitant procedure with ablation and LAAO device implantation requiring transseptal puncture\n* Is at least 18 years of age\n* Able and willing to comply with all study requirements\n\nExclusion Criteria:\n\n* Currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial without pre-approval from the study Sponsor\n* Pregnant or nursing\n* Known presence of intracardiac thrombus\n* Known existing circumferential pericardial effusion (\\>2 mm)\n* Previous interatrial septal patch or prosthetic atrial septal defect closure device\n* Any previous thromboembolic event with in the last 6 months\n* Known or suspected left atrial myxoma\n* Known or suspected myocardial infarction within the last two weeks\n* Unstable angina\n* Recent (within the last 3 months) cerebral vascular accident (CVA)\n* Patients with an active infection\n* Patients who do not tolerate anticoagulation therapy\n* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results",{"count":226,"type":21},60,[24],"This study is a prospective, acute, first-in-human, early feasibility study intended to assess the initial safety and performance of the Agilis™ Radiofrequency (RF) Transseptal (TSP) System in crossing the atrial septum for left atrial and left ventricular access during cardiac electrophysiology (EP) and interventional cardiology (IC) procedures. This study will be conducted in an acute setting. Subjects will be followed through hospital discharge, and no follow-up visits will be required for this study.",[230,231],"Cardiac Arrythmias","Left Atrial Appendage Closure","2026-05-29",{"date":212,"type":38},{"date":235,"type":38},"2026-02-16",{"date":237,"type":21},"2026-08-03",{"name":44,"class":45},3,{"id":241,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":25,"conditions":244,"keywords":245,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":250,"leadSponsor":251,"locationsCount":252},"100633202",{"count":20,"type":21},[24],[27,28,29],[31,32,33,29],"2026-05-22",{"date":248,"type":38},"2026-05-27",{"date":40,"type":38},{"date":42,"type":21},{"name":44,"class":45},13,{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":263,"conditions":264,"keywords":266,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":277},"100606902","balloon-based-pfa-ablation-post-approval-outcomes-for-paf-and-persaf-100606902","NCT07181590","BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF","BLAST-OFF","Inclusion Criteria:\n\n1. Documented symptomatic PAF or PersAF. Documentation requirements are as follows:\n\n   Paroxysmal:\n   * Physician's note indicating recurrent self-terminating AF AND\n   * One electrocardiographically documented PAF episode within 12 months prior to enrollment.\n\n   Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by\n   * Physician's note, AND either\n   * 24-hour Holter within 360 days prior to enrollment, showing continuous AF, OR\n   * Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:\n\n     * That are taken at least 7 days apart but less than 12 months apart\n     * If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent\u002Fenrollment\n     * The most recent electrocardiogram must be within 180 days of enrollment.\n\n   NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device.\n2. Plans to undergo a de novo ablation procedure with the Volt PFA Catheter due to symptomatic PAF or PersAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication\n3. At least 18 years of age\n4. Able and willing to comply with all trial requirements including pre-procedure, post- procedure, and follow-up testing and requirements\n5. Informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board\u002FEthics Committee (IRB\u002FEC) of the respective clinical trial site.\n\nExclusion Criteria\n\n1. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days\n2. Known presence of cardiac thrombus\n3. Known Left ventricular ejection fraction \\\u003C 35% as assessed with echocardiography within 360 days of index procedure\n4. New York Heart Association (NYHA) class III or IV heart failure\n5. Pregnant, nursing, or planning to become pregnant during the clinical investigation follow-up period\n6. Patients who have had a ventriculotomy or atriotomy within the preceding 30 days of procedure\n7. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days\n8. Unstable angina\n9. Stroke or TIA (transient ischemic attack) within the last 90 days\n10. Heart disease in which corrective surgery is anticipated within 180 days after procedure\n11. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state\n12. Contraindication to long term anti-thromboembolic therapy\n13. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation\n14. Previous left atrial surgical or left atrial catheter ablation procedure (including LAA closure device)\n15. Severe mitral regurgitation (regurgitant volume ≥ 60 mL\u002Fbeat, regurgitant fraction ≥ 50%, and\u002For effective regurgitant orifice area ≥ 0.40cm2).\n16. Previous tricuspid or mitral valve replacement or repair\n17. Patients with prosthetic valves\n18. Patients with a myxoma\n19. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt\n20. Stent, constriction, or stenosis in a pulmonary vein\n21. Rheumatic heart disease\n22. Hypertrophic cardiomyopathy\n23. Diagnosed with amyloidosis or atrial amyloidosis\n24. Active systemic infection\n25. Renal failure requiring dialysis\n26. Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms\n27. Presence of an implanted LAA closure device\n28. Patient is currently participating in another clinical study that may confound the results of this of this post market evaluation; for example, enrolled in another study with an active treatment arm\n29. Unlikely to survive the protocol follow up period of 12 months\n30. Presence of other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.\n31. Individuals without legal authority\n32. Individuals unable to read or write",{"count":261,"type":21},300,[24],"This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology.",[28,265,32,29],"Atrial Arrhythmia",[33,29,267,268],"Pulsed Field Ablation","Persistent Field Ablation","2026-05-21",{"date":271,"type":38},"2026-05-26",{"date":273,"type":38},"2025-12-11",{"date":275,"type":21},"2027-08",{"name":44,"class":45},22,{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":285,"enrollmentInfo":286,"targetDuration":287,"studyType":57,"phases":4,"briefSummary":288,"conditions":289,"keywords":291,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":239},"100607848","navitor-japan-study-100607848","NCT07193888","Navitor Japan Study","Navitor Japan Post-Market Study","Inclusion Criteria:\n\n1. Patient is eligible per the current approved indication after Heart Team discussion and intended to undergo a Navitor TAVI procedure.\n2. The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the EC of the respective clinical site.\n3. The patient and the treating physician agree that the subject will return for all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n1. Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU).\n2. Life expectancy \\\u003C 12 months from the time of informed consent due to non-cardiac co-morbid conditions.\n3. In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and\u002For follow-up visits or that could impact scientific integrity of the study.\n4. Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated.\n5. Inability to tolerate antiplatelet\u002Fanticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated.\n6. Currently participating in an investigational drug or device study that may confound the results of this study.\n7. Anatomy that makes insertion and endovascular access to the aortic valve difficult and\u002For impossible.","100 Years",{"count":111,"type":21},"12 Months","The Navitor Japan Study is designed to evaluate the safety and performance of the Navitor™ valve used in combination with the FlexNav™ delivery system in a contemporary, real-world setting.",[290],"Severe Aortic Stenosis",[292,293,294,295],"NAVITOR","Transcatheter aortic valve implantation (TAVI)","Aortic Stenosis","Cardiovascular Disease",{"date":271,"type":38},{"date":298,"type":38},"2025-10-30",{"date":300,"type":21},"2028-08",{"name":44,"class":45},{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":311,"conditions":312,"keywords":316,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":330},"100511097","aveir-dr-real-world-evidence-post-approval-study-100511097","NCT05935007","Aveir DR Real-World Evidence Post-Approval Study","Aveir Dual-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study","Eligibility Criteria:\n\n* Implanted with an Aveir DR leadless pacemaker\n* Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for -30 days after implant, except in the case of death within the 30-day period\n* Ability to link with Medicare fee-for-service data",{"count":310,"type":21},1805,"The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.",[313,314,315],"Cardiac Pacemaker","Arrythmia","Bradycardia",[317,318,319,320,321],"bradycardia","sick sinus rhythm","pacemaker","av block","vasovagal syncope","2026-05-18",{"date":324,"type":38},"2026-05-20",{"date":326,"type":38},"2023-10-31",{"date":328,"type":21},"2030-12-31",{"name":44,"class":45},1,{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":341,"conditions":342,"keywords":344,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":360},"100420927","annuloplasty-rings-and-band-post-market-clinical-follow-up-study-100420927","NCT04761120","Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study","Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study","ARB-PMCF","Inclusion Criteria:\n\n1. Subject is expected to undergo cardiac surgery in ≤90 days including at least one of the following:\n\n   1. implant of a Rigid Saddle Ring, Séguin Ring or a full Tailor Ring without cut zone removal for MR repair\n   2. implant of a full Tailor Ring without cut zone removal for TR repair, or\n   3. implant of a Tailor Band or partial Tailor Ring with cut zone removed for primary TR repair.\n2. Subject's cardiac surgery will be performed by a study investigator.\n3. Subject will be ≥18 years old at the time of their annuloplasty implant(s).\n4. Subject provides written informed consent and agrees to comply with all required study visits and procedures.\n\nExclusion Criteria:\n\n1. Subject is below the age of legal consent in the applicable jurisdiction or otherwise lacks legal authority to provide informed consent.\n2. Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent.\n3. Subject is expected to have active endocarditis at the time of their Abbott annuloplasty device implant(s).\n4. Subject cannot be unambiguously assigned to a treatment group due to missing data on repair indication(s) or the model and configuration (cut zone removed or not) of their Abbott annuloplasty implant(s).\n5. Subject is participating in another clinical investigation including any treatment outside the investigative site's usual standard of care.\n6. Subject has anomalous anatomy or medical, surgical, psychiatric or social history or conditions that, in the investigator's opinion, would limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements",{"count":340,"type":21},550,"ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation. The devices included in this study are the SJM™ Rigid Saddle Ring and SJM Séguin Annuloplasty Ring, indicated for mitral valve repair, and the SJM Tailor™ Annuloplasty Ring and SJM Tailor Annuloplasty Band, indicated for mitral or tricuspid repair. Participants will be enrolled prior to undergoing mitral or tricuspid valve repair surgery including an Abbott annuloplasty implant and will complete annual follow-up visits through five years from implant. The study is being conducted to meet post-market clinical follow-up requirements of the European Union Medical Device Directives.",[141,62,343],"Valvular Heart Disease",[141,62,345,346,347,348,349,350,351,352],"Valve Surgery","Valve Repair","Annuloplasty Rings","Annuloplasty Bands","Rigid Saddle Ring","Séguin Annuloplasty Ring","Tailor Annuloplasty Ring","Tailor Annuloplasty Band","2026-05-14",{"date":322,"type":38},{"date":356,"type":38},"2021-02-01",{"date":358,"type":21},"2031-03",{"name":44,"class":45},17,{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":368,"targetDuration":370,"studyType":57,"phases":4,"briefSummary":371,"conditions":372,"keywords":374,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":385},"100601153","aveir-leadless-pacemaker-japan-pms-100601153","NCT07106788","Aveir Leadless Pacemaker Japan PMS","Aveir Leadless Pacemaker Japan Post Marketing Surveillance","Inclusion Criteria:\n\n* Patient is indicated for dual-chamber or single-chamber atrial leadless pacemaker system\n* Patient is a roll-over patient with existing Aveir DR leadless pacemaker system from the Aveir DR i2i IDE study\n* Patient is an upgrade patient with existing single-chamber Aveir leadless pacemaker that requires an upgrade to a dual-chamber Aveir leadless pacemaker system\n\nExclusion Criteria:\n\n* N\u002FA",{"count":369,"type":21},304,"3 Years","The primary purpose of the PMS is to collect safety information on the Aveir DR leadless cardiac pacemaker (LP) system in a population indicated for de novo dual-chamber pacing. Additionally, the PMS will collect data on rollover patients from the Aveir DR i2i IDE, Aveir AR LP in patients indicated for single-chamber pacing in the right atrium, and upgradeability in patients implanted with single-chamber Aveir atrial or ventricular LP that require an upgrade to a dual-chamber Aveir LP.",[373],"Leadless Pacemaker",[375,376],"leadless pacemaker","AVEIR","2026-05-11",{"date":379,"type":38},"2026-05-13",{"date":381,"type":38},"2025-05-26",{"date":383,"type":21},"2029-11",{"name":44,"class":45},14,{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":22,"phases":394,"briefSummary":395,"conditions":396,"keywords":401,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":252},"100609654","left-bundle-branch-area-pacing-lbbap-pmcf-study-100609654","NCT07217392","Left Bundle Branch Area Pacing (LBBAP) PMCF Study","LBBAP PMCF","Inclusion Criteria:\n\n1. Meets current clinical practice guidelines for implantation of Tendril STS 2088TC or UltiPace LPA1231 lead in the Left Bundle Branch Area\n2. Are ≥ 18 years of age or age of legal consent, whichever age is greater.\n3. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.\n4. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB\u002FEC.\n\nExclusion Criteria:\n\n1. Patient meets a standard contraindication for lead implant including:\n\n   1. the presence of tricuspid atresia\n   2. patients with mechanical tricuspid valves\n   3. patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate\n2. Patient is currently implanted with a pacemaker, ICD, or CRT-D\u002FP device\n3. Patient has had a previous unsuccessful attempt to place a lead in the LBB area\n4. Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant\n5. Patient is expected to receive a heart transplant within 6 months\n6. Patient life expectancy less than 6 months\n7. Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder\n8. Patient is enrolled or planning to enroll in another clinical trial that might confound the results of the present study\n9. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.\n10. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation.",{"count":84,"type":21},[24],"The objective of this study is to evaluate the safety and effectiveness of LBBA pacing\u002Fsensing in patients implanted with the Tendril STS 2088TC or UltiPace LPA1231 lead through 6 months post-implant.",[315,397,172,27,398,399,400],"Right Ventricular Pacing","Cardiac Disease","Left Bundle Branch Area Pacing","Conduction System Pacing",[402,403,404,405,317,406,407],"Right ventricular pacing","cardiac disease","heart failure","atrial fibrillation","left bundle branch area pacing","conduction system pacing","2026-04-22",{"date":410,"type":38},"2026-04-24",{"date":412,"type":38},"2025-07-24",{"date":414,"type":21},"2027-04-30",{"name":44,"class":45},{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":425,"conditions":426,"keywords":431,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":459},"100561461","abbott-structural-heart-device-registry-100561461","NCT06590467","Abbott Structural Heart Device Registry","SH-Registry","Inclusion Criteria:\n\n1. Subject is expected to undergo an implant attempt using one or more Abbott Structural Heart devices covered in this Registry or has previously undergone an implant attempt within the timeframes specified in the device-specific appendices.\n2. Subject is willing and able to comply with the site's standard of care follow-up schedule.\n3. Subject is willing to provide appropriate informed consent for Registry participation. For deceased subjects enrolled retrospectively, local regulations and EC\u002FIRB recommendations regarding consent and the protection of personal data must be followed.\n\nExclusion Criteria:\n\n1\\. Subject is participating in another clinical study that would affect the results of this Registry.",{"count":424,"type":21},2500,"The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting. The Registry primarily involves gathering data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. All devices used in these procedures must be commercially available to the participating site. A list of specific devices covered by the Registry are available upon request from the Sponsor. Data generated by the Registry will be used to meet regulatory requirements, such as the European Union Medical Device Regulations 2017\u002F745, that require active post-market clinical follow-up (PMCF) for all commercially available devices.",[173,427,428,429,430,343],"ASD - Atrial Septal Defect","VSD - Muscular Ventricular Septal Defect","PFO - Patent Foramen Ovale","PIVSD - Post Infarct Muscular Ventricular Septal Defect",[432,433,434,435,436,437,438,439,440,441,442,443,444,445,446,447,448,449,450],"Amplatzer","Amplatzer Septal Occluder","Amplatzer Multi-fenestrated (Cribriform) Occluder","Amplatzer Duct Occluder","Amplatzer Piccolo Occluder","Amplatzer Muscular VSD Occluder","Amplatzer Post-Infarct VSD Occluder","Amplatzer Talisman","Amplatzer TorqVue Delivery System","Amplatzer Sizing Balloon","Amplatzer Guidewire","Amplatzer Occluder devices","Surgical Valves","Epic Plus Aortic Valve","Epic Plus Mitral Valve","Epic Plus Supra Aortic Valve","Epic Max Aortic Valve","Bioprosthetic heart valve","Surgical tissue heart valve","2026-04-07",{"date":453,"type":38},"2026-04-13",{"date":455,"type":38},"2024-08-21",{"date":457,"type":21},"2039-11",{"name":44,"class":45},28,{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":22,"phases":468,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":277},"100443945","cephea-early-feasibility-study-100443945","NCT05061004","Cephea Early Feasibility Study","Key Inclusion Criteria:\n\n* Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and\u002For severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) per American Society of Echocardiography criteria.\n* LVEF ≥ 30%\n* In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.\n\nKey Exclusion Criteria:\n\n* Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.\n* Need for emergent or urgent surgery.",{"count":467,"type":21},50,[24],"The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.",[141],{"date":472,"type":38},"2026-04-08",{"date":474,"type":38},"2022-04-28",{"date":476,"type":21},"2031-03-01",{"name":44,"class":45},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":487,"conditions":488,"keywords":492,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":7},"100420397","valved-graft-pmcf-study-100420397","NCT04754217","Valved Graft PMCF Study","Valved Graft Post-Market Clinical Follow-up Study","Inclusion Criteria:\n\n* cardiac surgery including the implant of a VAVGJ or CAVGJ for native or prosthetic valve replacement\n\nExclusion Criteria:\n\n* anticoagulation therapy intolerant\n* active endocarditis\n* anatomical or medical, surgical, psychological or social contraindications",{"count":486,"type":21},260,"Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.",[489,490,491],"Aortic Valve Disease","Ascending Aorta Abnormality","Aortic Dissection",[493,494,495,496,497],"Aortic Root Replacement","Ascending Aorta Replacement","Valved Graft","CAVGJ","VAVGJ",{"date":453,"type":38},{"date":500,"type":38},"2021-07-13",{"date":502,"type":21},"2029-09",{"name":44,"class":45},{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":22,"phases":512,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":523},"100621648","a-clinical-evaluation-of-amj-401-100621648","NCT07373353","A Clinical Evaluation of AMJ-401","AMJ-401 Japan Clinical Trial","Inclusion Criteria\n\n1. Subject must be at least 18 years of age.\n2. Subject or a legally authorized representative must be able to provide written Informed Consent prior to any study related procedure, per site requirements.\n3. Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia, unstable angina, acute myocardial infarction) suitable for elective PCI.\n4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.\n5. Subject must be able to take dual antiplatelet therapy (DAPT) for minimum of 12 months following the index procedure and anticoagulants prior\u002Fduring the index procedure, and the subject has no known allergic reaction, hypersensitivity or contraindication to aspirin, clopidogrel, prasugrel, ticagrelor, ticlopidine or heparin.\n6. Female subjects of childbearing potential must not be pregnant\\* at screening and do not plan pregnancy for at least 12 months following the index procedure.\n\n   \\* Female subjects of child-bearing potential must have a negative pregnancy result within 7 days prior to the index procedure.\n7. Female subjects must not be breast-feeding at the time of the screening visit and will not be breast-feeding for at least 12 months following the index procedure.\n8. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 13 months following the index procedure.\n\nExclusion Criteria:\n\n1. Elective surgery planned within 12 months after the procedure that will require general anesthesia or discontinuing either aspirin or P2Y12 inhibitor.\n2. Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, PLLA, PDLLA, platinum, lactic acid, and lactide) that cannot be adequately pre-medicated.\n3. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.\n4. Subject with known diagnosis of ST-elevation myocardial infarction (STEMI) within 72 hours of the index procedure.\n5. The subject is currently experiencing clinical symptoms consistent with new onset acute myocardial infarction (AMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.\n6. Subject has an unstable cardiac arrhythmia which is likely to become hemodynamically unstable due to their arrhythmia\n7. Subject has a known left ventricular ejection fraction (LVEF) \\\u003C 30% (LVEF may be obtained at the time of the index procedure prior to subject registration if the value is unknown and the site Investigator believes it is necessary).\n8. The target vessel was treated by PCI within 12 months prior to index procedure.\n9. Prior PCI within the non-target vessel is acceptable if performed anytime \\> 30 days before the index procedure, or between 24 hours and 30 days before the index procedure if successful and uncomplicated.\n10. Subject requires future staged PCI either in target or non-target vessels.\n11. Subject has a malignancy that is not in remission.\n12. Subject is receiving immunosuppressant therapy or has known life-threatening immunosuppressive or life-threatening autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy, diabetes mellitus is not regarded as autoimmune disease.\n13. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.\n14. Subject has previously received or scheduled to receive radiotherapy to coronary artery (brachytherapy), or chest\u002Fmediastinum.\n15. Subject is receiving or will require chronic anticoagulation therapy (e.g., warfarin).\n16. Subject has a platelet count \\\u003C 100,000 cells\u002Fmm3 or \\> 700,000 cells\u002Fmm3.\n17. Subject has documented or suspected cirrhosis of Child-Pugh ≥ Class B.\n18. Subject has known renal insufficiency:\n\n    * Dialysis at the time of screening or\n    * An estimated GFR \\\u003C 30 ml\u002Fmin\u002F1.73m2\n19. Subject has a high risk of bleeding, or;\n\n    * Subject has a history of bleeding diathesis or coagulopathy.\n    * Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.\n    * Subject has prior intracranial bleed (including severe permanent neurologic deficit that seems to be caused by previous intracranial bleeding).\n    * Subject has known intracranial pathology that may cause intracranial bleeding per investigator assessment (e.g., untreated aneurysm greater than 5 mm, arteriovenous malformation)\n    * Subject will refuse blood transfusions.\n    * Subject is receiving antiplatelet medication other than aspirin or P2Y12 inhibitor for the treatment of another condition and cannot discontinue them\n20. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months,\n21. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion via any vessel.\n22. Subject has life expectancy \\\u003C 3 years.\n23. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.\n24. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.\n25. Subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g., subordinate hospital staff or sponsor staff).",{"count":467,"type":21},[24],"A Clinical Evaluation of AMJ-401 in the Treatment of Subjects with Ischemic Heart Disease in Japan",[515],"Ischemic Heart Disease (IHD)","2026-04-06",{"date":451,"type":38},{"date":519,"type":38},"2025-12-17",{"date":521,"type":21},"2031-10-31",{"name":44,"class":45},10,{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":530,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":534,"conditions":535,"keywords":536,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":330},"100632128","triclip-japan-post-approval-study-100632128","NCT07509658","TriClip Japan Post-Approval Study","A Prospective, Single-arm, Multi-center, Observational, Post-approval Study Designed to Confirm the Safety and Efficacy of the TriClip System in Japan.","TriClip JP PAS","Inclusion Criteria:\n\n* Subjects are eligible to receive the TriClip System per the current approved indications for use (IFU)\n* Subjects provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.\n\nExclusion Criteria:\n\n* There are no exclusion criteria\n* Please note: It is not recommended that subjects enrolled in the study participate in any other therapeutic clinical study.",{"count":533,"type":21},250,"The goal of this observational post approval study is to confirm the safety and efficacy of the TriClip System when used in routine clinical practice in the Japanese population and to fulfill post-market requirements following commercial approval in Japan.",[62],[537,62,538],"TR","TriClip",{"date":540,"type":38},"2026-04-03",{"date":542,"type":38},"2026-03-02",{"date":544,"type":21},"2029-12-15",{"name":44,"class":45},{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":553,"conditions":554,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":330},"100575997","cardiomems-hf-system-coverage-with-evidence-development-study-100575997","NCT06779552","CardioMEMS HF System Coverage With Evidence Development Study","Inclusion Criteria:\n\n1. Subject implanted with a CardioMEMS pressure sensor (treatment arm only)\n2. Subject \\>=18 years of age at time of implant\n3. Subject has a history of acute decompensated HF or HF-related congestion defined by at least one of the following qualifying event types: HF hospitalization, elevated BNP\u002FNT-proBNP\n\nExclusion Criteria:\n\n1. Subject has history of heart transplant or durable mechanical circulatory device\n2. Subject hospitalized with cardiogenic shock or sepsis\n3. Subject received prior PA pressure sensor implant (control arm only)",{"count":56,"type":21},"The purpose of the CardioMEMS CED Study is to determine if pulmonary artery (PA) pressure-guided heart failure management using the CardioMEMS™ HF System improves long-term health outcomes in heart failure (HF) patients in the real-world setting.",[172],"2026-03-30",{"date":540,"type":38},{"date":558,"type":38},"2025-02-07",{"date":560,"type":21},"2032-03",{"name":44,"class":45},{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":22,"phases":570,"briefSummary":469,"conditions":571,"keywords":572,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":239},"100611773","cephea-south-america-feasibility-study-100611773","NCT07244939","Cephea South America Feasibility Study","Key Inclusion Criteria:\n\n* Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and\u002For severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) per American Society of Echocardiography criteria\n* LVEF ≥ 30%\n* In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery\n\nKey Exclusion Criteria:\n\n* Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function\n* Need for emergent or urgent surgery",{"count":569,"type":21},20,[24],[141,142],[573,150],"Symptomatic mitral valve disease","2026-02-05",{"date":576,"type":38},"2026-02-06",{"date":578,"type":38},"2025-06-17",{"date":580,"type":21},"2028-09",{"name":44,"class":45},{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":586,"acronym":587,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":590,"conditions":591,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":607},"100368019","abbott-dbs-post-market-study-of-outcomes-for-indications-over-time-100368019","NCT04071847","Abbott DBS Post-Market Study of Outcomes for Indications Over Time","ADROIT","Inclusion Criteria:\n\n1. Subject is scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 180 days.\n2. Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.\n\nExclusion Criteria:\n\n1. Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.\n2. Subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.\n3. Study center is located in the United States, and indication for DBS implant is not Parkinson's disease or disabling tremor.\n4. Study center is located in the United States, and the intended lead implant location is not at, or in close proximity to, the STN, GPi, or VIM thalamus.",{"count":56,"type":21},"The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.",[592,593,594,595,596,597,598],"Movement Disorders","Parkinson Disease","Essential Tremor","Tremor","Dystonia","Primary Dystonia","Secondary Dystonia","2026-01-07",{"date":601,"type":38},"2026-01-08",{"date":603,"type":38},"2019-11-26",{"date":605,"type":21},"2030-09",{"name":44,"class":45},48,{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":612,"acronym":613,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":615,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":617,"conditions":618,"keywords":620,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":630},"100352990","long-term-real-world-outcomes-study-on-patients-implanted-with-a-neurostimulator-100352990","NCT03876054","Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator","REALITY","Inclusion Criteria:\n\n1. Subject must provide written informed consent prior to any clinical investigation related procedure.\n2. Subject is at least 18 years (or the minimum age required by local law to consent for participation in a clinical investigation) or older at the time of enrollment.\n3. Subject is scheduled to have an Abbott neurostimulation system implanted within 60 days of baseline.\n4. Subject has a baseline (with no stimulation) pain NRS of ≥ 6.\n\nExclusion Criteria:\n\n1. Subject is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.\n2. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements.\n3. Subject has or is scheduled to receive an intrathecal pump.\n4. Subject is part of a vulnerable population.\n5. Subject has an existing implanted neuromodulation device to address their chronic pain.",{"count":616,"type":21},2000,"The REALITY study is a prospective, post-market, non-randomized, multi-center, single-arm, open-label study intended to collect short- and long-term safety and effectiveness data on various populations implanted with Abbott's neurostimulation systems.",[619],"Chronic Pain",[621,622],"spinal cord stimulation","dorsal root ganglion stimulation","2026-01-05",{"date":599,"type":38},{"date":626,"type":38},"2019-03-13",{"date":628,"type":21},"2029-12",{"name":44,"class":45},55,{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":636,"acronym":637,"eligibilityCriteria":638,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":639,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":641,"conditions":642,"keywords":643,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":330},"100586850","triclip-ced-rwe-study-100586850","NCT06920745","TriClip CED RWE Study","TRIClip CoverAge With Evidence Development (CED) Real-World Evidence (RWE) Study (TRICARE)","TRICARE","Inclusion Criteria:\n\n* Patients ≥ 18 years of age at time of implant\n* Patients with symptomatic, severe or greater Tricuspid Regurgitation who have received the TriClip system (treatment group) or have not undergone T-TEER (control group)\n\nExclusion Criteria:\n\n* Patients with less than severe Tricuspid Regurgitation\n* Patients with a prior history of surgical or transcatheter tricuspid valve replacement\n* Patients with a surgical or transcatheter aortic or mitral valve intervention within 90 days prior to index",{"count":640,"type":21},2200,"This Coverage with Evidence Development (CED) study evaluates the long-term health outcomes of patients with symptomatic, severe or greater Tricuspid Regurgitation who received a Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) procedure using the TriClip system.",[62],[538,644,645],"Coverage with Evidence Development","Tricuspid Transcatheter Edge-to-Edge Repair","2025-08-06",{"date":648,"type":38},"2025-08-11",{"date":650,"type":38},"2025-07-08",{"date":652,"type":21},"2032-07",{"name":44,"class":45},""]