[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632244":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":19,"locations":10,"responsibleParty":26,"collaborators":10,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":34,"eligibilityCriteria":35,"healthyVolunteers":30,"sex":36,"minAge":37,"maxAge":38,"enrollmentInfo":39,"targetDuration":10,"studyType":42,"phases":10,"briefSummary":43,"conditions":44,"keywords":10,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":10},{"fullName":5,"class":6},"Johnson & Johnson Medical (Shanghai) Ltd.","INDUSTRY",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"General Anesthesia Group",null,"Participants undergoing ablation for treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF) under general anesthesia will undergo pulsed field ablation (PFA) with Varipulse PFA catheter system including Varipulse catheter and Trupulse generator.",{"label":13,"type":10,"description":14,"interventionNames":10},"Non-General Anesthesia Group","Participants undergoing ablation for treatment of symptomatic PAF under the non-general anesthesia, including participants with deep sedation and conscious sedation will undergo PFA with the Varipulse PFA catheter system including Varipulse catheter and Trupulse generator.",[16],{"name":17,"affiliation":5,"role":18},"Johnson & Johnson Medical (Shanghai) Ltd. Clinical Trial","STUDY_DIRECTOR",[20],{"name":21,"role":22,"phone":23,"phoneExt":24,"email":25},"YanTing Zhang","CONTACT","13162835013","+86","yzhan365@ITS.JNJ.com",{"type":27,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100632244","a-study-of-varipulse-catheter-in-participants-with-paroxysmal-atrial-fibrillation-under-optimized-sedation-100632244",false,"NCT07511166","A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation","High-quality Pulmonary Veins Isolation Using Varipulse Catheter Under Contact and Continuity Guidance in Patients With Paroxysmal Atrial Fibrillation Under Optimized Sedation","GreatPFA","Inclusion criteria:\n\n* Diagnosed with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF) or intolerable to class I and\u002For III antiarrhythmic drugs (AAD) based on medical records\n* Age 18-80 years\n* Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements\n* Signed patient informed consent form (ICF)\n\nExclusion criteria:\n\n* Atrial fibrillation (AF) secondary to electrolyte imbalance, hyperthyroidism, or reversible or non-cardiac cause\n* Previous left atrium (LA) ablation or surgery\n* Left atrium diameter (LAD) greater than (\\>) 50 millimeters (mm) by transthoracic echocardiography (TTE)\n* Left ventricular ejection fraction (LVEF) less than (\\\u003C) 40 percent (%)\n* Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study\n* Current enrollment in an investigational study evaluating another device or drug\n* Women who are pregnant (as evidenced by pregnancy test or oral confirmation if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation\n* Life expectancy less than 12 months\n* Presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (IFU)\n* Presenting contra-indications for catheter ablation at physicians' discretion, for example LA\u002FLeft atrial appendage (LAA) thrombus, systematic infection, situations preventing catheter access\n* Other conditions that, at discretion of the investigators, would preclude enrollment in this study","ALL","18 Years","80 Years",{"count":40,"type":41},300,"ESTIMATED","OBSERVATIONAL","The main purpose of the study is to assess how well the standard ablation procedure (Varipulse Catheter) works over long term when used with different types of anesthesia in participants with symptomatic paroxysmal atrial fibrillation (PAF, irregular heartbeat that comes and goes on its own, causing noticeable symptoms like a racing heart, or shortness of breath).",[45],"Atrial Fibrillation","NOT_YET_RECRUITING","2026-06-04",{"date":49,"type":50},"2026-06-05","ACTUAL",{"date":52,"type":41},"2026-07-01",{"date":54,"type":41},"2028-03-28",{"name":5,"class":6}]