[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"paroxysmal-af\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:paroxysmal-af":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,46,68,90,116,146,159,180,204,232,258],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":19,"type":20},240,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Atrial Fibrillation (AF)","Paroxysmal AF","Persistent Atrial Fibrillation",[30,31,32,28],"Left Atrial Appendage","Atrial Fibrillation","Paroxysmal Atrial Fibrillation","RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":37},"2026-03-31",{"date":41,"type":20},"2028-02-28",{"name":43,"class":44},"Abbott Medical Devices","INDUSTRY",16,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"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":54,"type":20},500,"OBSERVATIONAL","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.",[27],"2026-06-28",{"date":60,"type":37},"2026-06-30",{"date":62,"type":37},"2025-10-23",{"date":64,"type":20},"2029-12-31",{"name":66,"class":44},"Boston Scientific Corporation",1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"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":77,"type":20},250,[23],"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).",[31,28,27],"2026-06-26",{"date":83,"type":37},"2026-06-29",{"date":85,"type":37},"2025-02-17",{"date":87,"type":20},"2027-09-15",{"name":66,"class":44},4,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":104,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100616687","horizon-360-protocol-for-the-treatment-of-paroxysmal-atrial-fibrillation-with-the-sphere-360-catheter-and-affera-mapping-and-ablation-system-horizon-360-100616687","NCT07308847","Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)","Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Prospective, Single Arm, Unblinded Pre-market Clinical Study to Evaluate the Safety and Effectiveness of the Sphere-360 Catheter and Affera Mapping and Ablation System for Treating Paroxysmal Atrial Fibrillation (PAF)","Horizon 360","Inclusion Criteria:\n\n1. A diagnosis of recurrent symptomatic PAF, which is defined as continuous AF episode lasting longer than 30 seconds but terminates spontaneously or with intervention within 7 days of onset, documented by the following:\n\n   1. a physician's note indicating at least 2 symptomatic PAF episodes occurring within 6 months prior to enrollment; and\n   2. at least 1 electrocardiographically documented episode within 12 months prior to enrollment\n2. Adults who are ≥18 and ≤80 years of age on the day of enrollment.\n3. Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.\n\nExclusion Criteria:\n\n1. Continuous AF lasting more than 7 days. This includes persistent atrial fibrillation (PsAF) (both early or long-standing) by diagnosis or continuous duration \\> 7 days\n2. AF that required three (3) or more distinct cardioversions in the preceding 12 months.\n3. LA anteroposterior \\> 5.0 cm (by MRI, CT, or TTE)\n4. Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices\n5. Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder\u002Finsertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period\n6. Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure\n7. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder\u002Finsertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)\n8. Presence of any pulmonary vein stents\n9. Known pre-existing pulmonary vein stenosis\n10. Pre-existing hemidiaphragmatic paralysis\n11. Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, and any prior atriotomy\n12. Moderate to severe aortic or mitral valve stenosis\n13. Moderate to severe mitral regurgitation (i.e., 3+ or 4+ MR)\n14. Any cardiac surgery, myocardial infarction, PCI \u002F PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date\n15. Unstable angina\n16. NYHA Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 40% measure by acceptable cardiac testing (e.g. TTE), or planned transplant or left ventricular assist device (LVAD)\n17. Severe lung disease, primary pulmonary hypertension, or any lung disease with abnormal blood gases or requiring supplemental oxygen\n18. Rheumatic heart disease\n19. Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder\n20. Contraindication to or unwillingness to use systemic anticoagulation\n21. Documented left atrial thrombus on imaging\n22. Active systemic infection or sepsis\n23. Hypertrophic cardiomyopathy\n24. Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity\n25. Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date\n26. Carotid stenting or endarterectomy\n27. History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure\n28. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence\n29. Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed\n30. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic\n31. Known allergies or hypersensitivities to adhesives\n32. Body mass index \\> 40 kg\u002Fm2\n33. Atrial myxoma\n34. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.\n35. Renal insufficiency with an estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2, or any history of renal failure requiring dialysis or renal transplant\n36. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant\n37. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation\n38. Known drug or alcohol dependency\n39. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results.\n40. Treatment with Amiodarone within the 3 months prior to enrollment\n41. Amyloid heart disease (cardiac amyloidosis)","80 Years",{"count":100,"type":20},300,[23],"The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives. No single site may contribute more than 15% of the enrollments.",[27],[32,31,105],"Pulsed Field Ablation","2026-06-10",{"date":108,"type":37},"2026-06-12",{"date":110,"type":37},"2026-01-15",{"date":112,"type":20},"2027-11-22",{"name":114,"class":44},"Medtronic Cardiac Ablation Solutions",22,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":98,"enrollmentInfo":124,"targetDuration":4,"studyType":21,"phases":126,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":145},"100576374","coherent-sine-burst-electroporation-cse-ablation-system-us-ide-study-for-patients-with-atrial-fibrillation-100576374","NCT06784466","Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation","Coherent Sine Burst Electroporation (CSE) Ablation System US Investigational Device Exemption (IDE) Study for Patients With Atrial Fibrillation","COHERENT-AF","Inclusion Criteria:\n\n1. Patients between the ages of 18 and 80 years, or older than 18 if required by local law.\n2. Diagnosis of drug refractory, recurrent, paroxysmal or persistent AF:\n\n   a. Symptomatic paroxysmal AF that is less than 7 days in continuous duration, documented by the following: i. Physician documentation of symptomatic recurrent PAF (2 or more episodes) within 6 months prior to enrollment AND ii. At least 1 documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment.\n\n   b. Symptomatic persistent AF that is sustained beyond 7 days and less than 1 year (≥ 7 and ≤ 365 days), documented by the following: i. Physician documentation of at least 1 symptomatic persistent AF episode within 6 months prior to enrollment.\n\n   ii. Either a 24-hour continuous ECG recording documenting continuous AF OR 2 ECGs from any regulatory cleared rhythm monitoring device showing continuous AF taken at least 7 days apart, within 6 months prior to enrollment.\n3. Effectiveness failure of, intolerance to, or a specific contraindication to at least one Class I or III anti-arrhythmic drug.\n4. Willing and able to give informed consent.\n5. Willingness, ability, and commitment to participate in baseline, follow-up, and rhythm monitoring evaluations for the full length of the study.\n6. Life expectancy \\>1 year.\n\nExclusion Criteria:\n\n1. In the opinion of the Investigator, any known contraindication to an AF ablation (including present left atrial \\[LA\\] thrombus), trans-esophageal echocardiogram (TEE) or computed tomography (CT) scan, or anticoagulation.\n2. Any duration of continuous AF lasting longer than 12 months.\n3. History of any previous left atrial ablation or surgical procedure, including prior left atrial appendage closure.\n4. AF secondary to electrolyte imbalance, thyroid disease, alcohol, or any other reversible or non-cardiac cause.\n5. Left ventricular ejection fraction (LVEF) \\\u003C 35% within 6 months of enrollment (e.g. transthoracic echocardiogram (TTE), multiple-gated acquisition (MUGA), magnetic resonance imaging (MRI), nuclear stress test).\n6. New York Heart Association (NYHA) Class III or IV.\n7. Left atrial diameter \\> 5.0 cm (anteroposterior) within 6 months of enrollment (MRI, CT, TTE, TEE, or physician's note) or non-indexed volume \\>100mL if left atrial diameter is not available.\n8. Current or anticipated implant of a permanent pacemaker, implantable cardioverter or resynchronization device, interatrial baffle, foramen ovale occluder, LA appendage closure, or active implantable\u002Finsertable cardiac loop recorder\u002Fmonitor at the time of the ablation procedure.\n9. Body mass index (BMI) \\>40.\n10. Patients who have not been on anticoagulation therapy for at least 3 weeks prior to the Index Procedure.\n11. Previous cardiac surgery, myocardial infarction, percutaneous coronary intervention or angioplasty (PCI\u002FPTCA) or coronary artery stenting within 3 months prior to enrollment.\n12. Symptomatic valvular disease, history of cardiac valve surgery, or prosthetic mitral and tricuspid valve(s).\n13. Presence of pulmonary vein abnormalities of stenosis or stenting.\n14. Primary pulmonary hypertension.\n15. Uncontrolled or untreated hypertension (two measurements of \\>180mmHg systolic or \\>110 mmHg diastolic at baseline).\n16. Pre-existing hemi-diaphragmatic paralysis.\n17. Renal insufficiency with an estimated glomerular filtration rate (eGFR) \\\u003C 40 mL\u002Fmin\u002F1.73 m2, or any history of renal dialysis or renal transplant.\n18. Rheumatic heart disease.\n19. Unstable angina or ongoing myocardial ischemia.\n20. Hypertrophic cardiomyopathy, advanced restrictive cardiomyopathy, or severe left ventricular hypertrophy (left ventricular thickness \\>15mm).\n21. History of blood clotting or bleeding disease (e.g., thrombocytosis).\n22. History of documented cerebral infarction, transient ischemic attack, or systemic embolism within 6 months prior to enrollment.\n23. Active systemic infection.\n24. Active malignancy or history of treated malignancy within 12 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma, or non-metastatic prostate or breast cancer with life expectancy remaining \\>1 year).\n25. Pregnant or lactating (current or anticipated during study follow-up).\n26. Current enrollment in any other clinical study where testing or results from that study may interfere with the procedure or outcomes measurement for this study.\n27. Any other condition that, in the judgment of the Investigator, makes the patient:\n\n    1. Unlikely to benefit from an AF ablation procedure (e.g., advanced infiltrative cardiomyopathies, severe mitral stenosis or regurgitation, and\u002For cor pulmonale, etc.), or\n    2. A poor candidate for the study (e.g., vulnerable patient population, mental illness, addictive disease, terminal illness, and extensive travel away from the research center).",{"count":125,"type":20},360,[23],"To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.",[26,129,27],"Persistant Atrial Fibrillation",[131,132,133,134,135],"atrial fibrillation","ablation","coherent sine-burst","electroporation","pulsed field ablation","2026-06-04",{"date":138,"type":37},"2026-06-05",{"date":140,"type":37},"2025-09-10",{"date":142,"type":20},"2027-08",{"name":144,"class":44},"Arga Medtech SA",27,{"id":147,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":24,"conditions":150,"keywords":151,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":156,"leadSponsor":157,"locationsCount":158},"100633202",{"count":19,"type":20},[23],[26,27,28],[30,31,32,28],"2026-05-22",{"date":154,"type":37},"2026-05-27",{"date":39,"type":37},{"date":41,"type":20},{"name":43,"class":44},13,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":168,"conditions":169,"keywords":171,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":179,"locationsCount":115},"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":100,"type":20},[23],"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.",[27,170,31,28],"Atrial Arrhythmia",[32,28,105,172],"Persistent Field Ablation","2026-05-21",{"date":175,"type":37},"2026-05-26",{"date":177,"type":37},"2025-12-11",{"date":142,"type":20},{"name":43,"class":44},{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":21,"phases":189,"briefSummary":190,"conditions":191,"keywords":192,"overallStatus":194,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":201,"locationsCount":4},"100631350","the-effect-of-pulse-field-ablation-of-atrial-fibrillation-involving-posterior-wall-ablation-on-atrial-mechancis-assessed-by-cardiac-magnetic-resonance-imaging-100631350","NCT07499531","The Effect of Pulse Field Ablation of Atrial Fibrillation Involving Posterior Wall Ablation on Atrial Mechancis Assessed by Cardiac Magnetic Resonance Imaging","PF-MRI+","Inclusion Criteria:\n\n* Patient age ≥ 18\n* Established diagnosis of persistent or paroxysmal atrial fibrillation with a I\u002FIIa\u002FIIb indication for catheter ablation (ESC 2020 guidelines)\n* AF ablation procedure planned using pulsed-field ablation and including at least pulmonary vein isolation and posterior wall isolation\n* Episode of AF documented by ECG within the last 12 months\n* Patient able to give written informed consent\n* If female of childbearing potential, have a negative serum pregnancy test and using effective contraception\n* Be affiliated with a French social security system or entitled\n\nExclusion Criteria:\n\n* Only pulmonary vein isolation is scheduled\n* Atrial fibrillation present at ECG during the pre-ablation (V1a) visit\n* Contraindication to oral anticoagulation\n* Intracardiac thrombus\n* Previous ablation in the left atrium\n* Previous heart surgery\n* Significant valvular heart disease defined as any moderate (grade 3) or severe (grade 4) mitral regurgitation, mitral stenosis, aortic regurgitation, aortic stenosis, tricuspid regurgitation, or tricuspid stenosis\n* Contraindication to perform MRI or using the DOTAREM™ contrast product (pacemaker, defibrillator, foreign body or prosthesis, old generation heart valves, old generation ferromagnetic vascular surgical clips, percutaneous devices for endocranial aneurysms, neurosimulator, cochlear implants, automated injection device such as insulin pump, and more generally any non-removable electronic device, severe kidney disease with GFR \\\u003C 30 mL\u002Fmin, documented hypersensitivity to gadoteric acid or to excipients, severe claustrophobia)\n* Patient on AME (state medical aid)\n* Pregnant or breast-feeding female\n* Patient protected by law (guardianship, tutelage measure, deprived of liberty)\n* Participation in another interventional study or being in the exclusion period at the end of a previous study.",{"count":188,"type":20},39,[23],"Assessing the impact of a new atrial fibrillation (AF) catheter ablation energy on left atrial structure and function is of crucial importance.\n\nThe goal of this clinical trial is to assess the effect of pulsed-field ablation of atrial fibrillation on left atrial structure.",[129,27],[193],"Catheter Ablation","NOT_YET_RECRUITING","2026-03-24",{"date":197,"type":37},"2026-03-30",{"date":199,"type":20},"2026-04",{"date":199,"type":20},{"name":202,"class":203},"Assistance Publique - Hôpitaux de Paris","OTHER",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":98,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":214,"briefSummary":215,"conditions":216,"keywords":217,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":67},"100611133","durability-of-pulmonary-vein-isolation-using-a-variable-loop-biphasic-pulsed-field-ablation-catheter-in-patients-with-paroxysmal-atrial-fibrillation-100611133","NCT07236619","Durability of Pulmonary Vein Isolation Using a Variable-Loop Biphasic Pulsed Field Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation","Durability of Pulmonary Vein Isolation Using a Variable-Loop Biphasic Pulsed Field Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation: a Prospective Remapping Study","VARIFY","Inclusion Criteria: 1) History of symptomatic paroxysmal AF; 2) Participants who are indicated for a PVI according to the 2020 ESC guidelines for the diagnosis and management of AF; 3) Participants who are willing and capable of undergoing a mandatory repeat procedure 2-3 months after the index procedure; 4) Participants whose age is 18-80 years. 5) Participants who are willing and capable of providing informed consent.\n\nExclusion Criteria: 1) Any known contraindication to an AF ablation or anticoagulation; 2) History of previous LA ablation or surgical treatment of AF, atrial flutter, or atrial tachycardia; 3) AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause; 4) Significant structural heart disease; 5) History of blood clotting or bleeding disease; 6) Severe kidney disease (glomerular filtration rate \\\u003C30 ml\u002Fmin\u002F1.73 m2); 7) Stroke or transient ischemic attack \\\u003C3 months prior to enrollment; 8) Active systemic infection; 9) Pregnant, lactating, or women of childbearing potential who are, or plan to become, pregnant during the time of the study; 10) Participants who are currently enrolled in another investigational study or registry that would directly interfere with the current study.",{"count":213,"type":20},20,[23],"The VARIFY study is designed to find out how durable pulmonary vein isolation (PVI) is after treatment with the VARIPULSE pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation (AF). AF is a common heart rhythm disorder caused by abnormal electrical signals coming from the pulmonary veins. In a PVI procedure, these veins are electrically isolated to prevent AF from recurring. Sometimes, the veins reconnect over time, which can lead to a return of arrhythmia. PFA is a new, non-thermal technology that uses short electrical pulses to safely and precisely treat heart tissue, reducing the risk of damage to nearby structures. The VARIPULSE system is one of these new PFA platforms. In this study, 20 adult patients with paroxysmal AF will undergo PVI using the VARIPULSE system. After 2-3 months, each patient will have a second planned procedure to check whether the pulmonary veins remain isolated. Any reconnections found will be treated immediately. The main goal is to determine how often the pulmonary veins stay durably isolated after the initial VARIPULSE treatment. Secondary goals include assessing the amount of scar tissue in the left atrium, recording any complications, and evaluating rhythm outcomes after one year. The results will help determine how effective and reliable the VARIPULSE system is for long-term treatment of AF.",[27],[218,219,220,221,222],"Varipulse","Catheter ablation","Atrial fibrillation","Paroxysmal atrial fibrillation","Pulmonary vein isolation","2025-11-15",{"date":225,"type":37},"2025-11-19",{"date":227,"type":37},"2025-09-27",{"date":229,"type":20},"2027-03",{"name":231,"class":203},"Erasmus Medical Center",{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":21,"phases":242,"briefSummary":243,"conditions":244,"keywords":245,"overallStatus":194,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":67},"100601609","svc-isolation-in-redo-af-ablation-with-isolated-pv-100601609","NCT07112716","SVC-isolation in Redo-AF Ablation With Isolated PV","Superior Vena Cava Isolation With Radiofrequency Ablation in Patients With Recurrent Paroxysmal Atrial Fibrillation and Durably Isolated Pulmonary Veins: A Multicenter Study","SVC-RESCUE-AF","Inclusion Criteria:\n\n1. Age \\> 18 years.\n2. Confirmed diagnosis of recurrent paroxysmal AF\n3. Previous transcatheter PVI-only procedure for AF.\n4. Evidence of persistently isolated pulmonary veins at repeat procedure.\n5. Signed informed consent.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Pregnancy.\n* Concomitant investigation treatments.\n* Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.\n* Lesions other than PVI performed during first procedure\n* Persistent AF at recurrence.\n* Evidence of pulmonary vein reconnection at repeat procedure.\n* Any additional lesion performed beyond SVC isolation during repeat procedure (in the empirical SVC isolation group only).",{"count":241,"type":20},100,[23],"Atrial fibrillation is the most common arrhythmia in the population and is often caused by arrhythmogenic foci located in the pulmonary veins. For this reason, the first attempt in atrial fibrillation catheter ablation procedures is to isolate these structures (the procedure is called indeed \"pulmonary vein isolation\"), which results in abolishment of arrhythmia recurrence in up to 85% of patients at short and mid-term follow-up. However, a subset of patients experience an atrial tachyarrhytmia recurrence and a second catheter ablation procedure has to be performed. If pulmary vein isolation is proven to be durable, other arrhythmogenic foci could be implicated in arrhythmia recurrence. Among extra-pulmonary vein foci, superior vena cava has been described as the most frequently involved in atrial fibrillation initiation. Therefore, its ablation could result in improved freedom from atrial fibrillation episodes during follow-up. In the present study, we sought to evaluate the safety and effectiveness of empirical superior vena cava isolation in terms of arrhythmia-free survival in patients with paroxysmal atrial fibrillation recurrence despite durable pulmonary vein isolation.",[27],[220,246,247,248],"Paroxysmal","Recurrence","Superior Vena Cava Isolation","2025-08-02",{"date":251,"type":37},"2025-08-08",{"date":253,"type":20},"2025-09-01",{"date":255,"type":20},"2027-07-01",{"name":257,"class":203},"Centro Medico Teknon",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":266,"enrollmentInfo":267,"targetDuration":4,"studyType":21,"phases":269,"briefSummary":270,"conditions":271,"keywords":272,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":67},"100565846","evaluation-of-the-impact-of-pulsed-field-ablation-on-autonomic-nervous-system-modulation-in-paroxysmal-atrial-fibrillation-100565846","NCT06647485","Evaluation of the Impact of Pulsed Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation","A Prospective Randomized Study for the Evaluation of the Impact of Point-by-Point Pulse Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation","GPfIRE","Inclusion Criteria:\n\n* Symptomatic Paroxysmal Atrial Fibrillation (AF) that terminates spontaneously or with intervention within 7 days of onset\n* Age range: 18-70 years\n* Willing and capable of providing informed consent\n* Able and willing to comply with all pre-, post-, and follow-up testing and requirements\n\nExclusion Criteria:\n\n* Previously diagnosed Persistent AF (\\> 7 days in duration)\n* Previous LA ablation\n* Previous cardiac surgery\n* Myocardial Infarction within the previous 3 months\n* Severely compromised Left Ventricular Ejection Fraction (LVEF\\<40%)\n* Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the pulsed electric field energy\n* Acute illness, active systemic infection, or sepsis\n* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.\n* Severe mitral regurgitation\n* Woman who are pregnant, lactating, or who are planning to become pregnant during the course of the clinical investigation","70 Years",{"count":268,"type":20},105,[23],"The objective of this clinical trial is to evaluate the impact of pulse field (PF) energy, both alone and in combination with radiofrequency (RF) energy, on vagal modulation during point-by-point pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). The effect of PF energy on ganglionated plexi (GP) will be assessed using heart rate variability (HRV) as a surrogate marker. Participants will be randomized into three groups: the PF-only group and the Hybrid group (PF posterior\u002FRF anterior) as the experimental arms, and the RF-only group as the control arm. HRV will be measured before and 24 hours after the PVI procedure. Additionally, cardio and neuro biomarkers (Troponin and S100B) will be measured pre-procedure and 20 minutes post-ablation. All participants will be followed for 12 months, with 24-hour Holter-ECG evaluations scheduled at 3, 6, and 12 months after the initial ablation procedure.",[26,27],[273,274,275,276,277,278,279],"vagal modulation","ganglionated plexi","pulsed field","dual-energy focal ablation","paroxysmal atrial fibrillation","heart rate variability","pulmonary vein isolation","2025-07-08",{"date":282,"type":37},"2025-07-10",{"date":284,"type":37},"2025-01-29",{"date":286,"type":20},"2026-12",{"name":288,"class":203},"VZW Cardiovascular Research Center Aalst"]