[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"persistant-atrial-fibrillation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:persistant-atrial-fibrillation":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100576374","coherent-sine-burst-electroporation-cse-ablation-system-us-ide-study-for-patients-with-atrial-fibrillation-100576374",false,"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).","ALL","18 Years","80 Years",{"count":21,"type":22},360,"ESTIMATED","INTERVENTIONAL",[25],"NA","To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.",[28,29,30],"Atrial Fibrillation (AF)","Persistant Atrial Fibrillation","Paroxysmal AF",[32,33,34,35,36],"atrial fibrillation","ablation","coherent sine-burst","electroporation","pulsed field ablation","RECRUITING","2026-07-13",{"date":40,"type":41},"2026-07-15","ACTUAL",{"date":43,"type":41},"2025-09-10",{"date":45,"type":22},"2027-08",{"name":47,"class":48},"Arga Medtech SA","INDUSTRY",27,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":71,"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":58,"type":22},39,[25],"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.",[29,30],[63],"Catheter Ablation","NOT_YET_RECRUITING","2026-03-24",{"date":67,"type":41},"2026-03-30",{"date":69,"type":22},"2026-04",{"date":69,"type":22},{"name":72,"class":73},"Assistance Publique - Hôpitaux de Paris","OTHER"]