[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638838":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":7,"responsibleParty":13,"collaborators":7,"id":15,"slug":16,"hasResults":17,"nctId":18,"briefTitle":19,"officialTitle":20,"acronym":7,"eligibilityCriteria":21,"healthyVolunteers":17,"sex":22,"minAge":23,"maxAge":24,"enrollmentInfo":25,"targetDuration":7,"studyType":28,"phases":7,"briefSummary":29,"conditions":30,"keywords":7,"overallStatus":32,"whyStopped":7,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":7},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"PROCEDURE","Focal Pulsed Field Ablation of the Coronary Sinus","This study utilizes focal pulsed-field ablation (PFA) specifically targeting the coronary sinus (CS) to achieve permanent electrical isolation of the mitral isthmus (MI). Unlike traditional radiofrequency ablation, this intervention delivers non-thermal, ultra-short high-voltage pulses that induce irreversible electroporation specifically in myocardial cells",{"type":14,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100638838","pulsed-field-ablation-in-the-coronary-sinus-feasibility-and-safety-of-a-novel-approach-for-mitral-isthmus-block-100638838",false,"NCT07577544","Pulsed Field Ablation in the Coronary Sinus: Feasibility and Safety of a Novel Approach for Mitral Isthmus Block","Safety, Efficacy and Mid-term Outcomes of Pulsed Field Ablation for Mitral Isthmus Ablation Through Epicardial Approach","Inclusion Criteria:\n\n* Symptomatic Atrial Fibrillation: participants must have a diagnosis of symptomatic paroxysmal or persistent atrial fibrillation.\n* Documentation: The arrhythmia must be documented by electrocardiogram or Holter monitoring.\n* Age Range: participants must be between 18 and 75 years of age.\n* Study Compliance: participants must be willing and able to comply with the post-procedural follow-up schedule.\n* Procedural Requirement: All patients must be candidates for linear ablation at the mitral isthmus (MI) and coronary sinus (CS) for substrate modification.\n\nExclusion Criteria:\n\n* Prior Cardiac Procedures: Patients with a history of prior heart surgery or Left Atrial Appendage Occlusion (LAAO) are excluded.\n* Heart Failure Severity: Individuals classified with New York Heart Association (NYHA) functional class III or IV are ineligible.\n* Renal Impairment: Patients with advanced renal failure, defined as an estimated glomerular filtration rate (eGFR) below 30 mL\u002Fmin\u002F1.73m², are excluded.\n* Intracardiac Thrombus: Any patient with a left atrial thrombus identified via transesophageal echocardiography (TEE) is excluded.","ALL","18 Years","75 Years",{"count":26,"type":27},30,"ESTIMATED","OBSERVATIONAL","Why This Study Is Important\n\n* Many patients with atrial fibrillation (AF) continue to experience abnormal heart rhythms even after receiving standard treatments.\n* Standard heat-based energy can be difficult to use in these areas because fast blood flow cools the tissue, and excessive heat may damage nearby structures like the right coronary artery.\n\nOur Approach\n\n* Investigators are testing a newer technology called pulsed field ablation (PFA).\n* Unlike traditional methods, PFA uses ultra-short electrical pulses rather than heat to target heart cells specifically while protecting neighboring nerves and blood vessels.\n* This study focuses on applying this energy within the coronary sinus to help achieve a more complete and lasting electrical block for the mitral isthmus.\n\nWhat To Expect\n\n* This study involves 30 participants who are already undergoing a catheter ablation procedure for atrial fibrillation.\n* The research team will monitor how successful the procedure is at immediately stopping the abnormal electrical signals.\n* Participants will have follow-up visits over six months to check for any returning heart rhythm issues and will receive a specialized heart scan (CTA) to ensure the nearby coronary arteries remain healthy",[31],"Atrial Fibrillation (AF)","NOT_YET_RECRUITING","2026-05-09",{"date":35,"type":36},"2026-05-13","ACTUAL",{"date":38,"type":27},"2026-05-15",{"date":40,"type":27},"2026-06-30",{"name":5,"class":6}]