[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632244":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":60,"studyPopulation":64,"armGroups":65,"interventions":60,"overallOfficials":72,"centralContacts":76,"locations":60,"responsibleParty":83,"collaborators":60,"id":85,"slug":60,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":60,"studyType":98,"phases":60,"briefSummary":99,"conditions":100,"keywords":60,"overallStatus":102,"whyStopped":60,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":60},{"fullName":5,"class":6},"Johnson & Johnson Medical (Shanghai) Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":60},[9],{"measure":10,"description":11,"timeFrame":12},"Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episode","Participants reporting freedom from documented (asymptomatic and symptomatic) atrial tachyarrhythmias (atrial fibrillation \\[AF\\], atrial tachycardia \\[AT\\] or atrial flutter \\[AFL\\] of unknown origin) episode based on 24-hour Holter will be reported. Additionally, criteria for effectiveness failure included following: 1) Greater (\\>) than 1 repeat ablations for AF, AT, and AFL of unknown origin in the blanking period or any repeat ablation or surgical treatment for AF, AT, and AFL of unknown origin; 2) Direct current or pharmacological cardioversion for AF, AT, and AFL of unknown origin and; 3) A Class I and\u002For Class III antiarrhythmic drugs (AAD) is prescribed for AF, AT, and AFL of unknown origin.","Day 91 to Day 365 post index procedure",[14,18,21,25,28,32,36,39,42,45,48,51,54,57],{"measure":15,"description":16,"timeFrame":17},"Acute Procedural Success","Acute procedural success, which is defined as confirmation of entrance block in all clinically relevant targeted pulmonary vein (PVs) after drugs challenge or pacing at the end of the index ablation procedure will be reported.","Intraoperative",{"measure":19,"description":20,"timeFrame":17},"Acute Reconnection","Participants with acute reconnection, which is identified by drugs challenge or pacing among all clinically relevant targeted PVs will be reported.",{"measure":22,"description":23,"timeFrame":24},"Repeat Ablation","Participants undergoing repeat ablation within the 12 month follow up period, including timing (blanking period or after blanking) will be reported.","Up to 12 months post-index procedure",{"measure":26,"description":27,"timeFrame":24},"PV Re-Connection","Participants reporting PV re-connection will be assessed and reported.",{"measure":29,"description":30,"timeFrame":31},"Pain Visual Analogue Scale (VAS) Score","VAS score will be measured prior to hospital discharge using a 10- point VAS, where 0 = no pain, 10 = worst imaginable pain. Higher score means greater severity.","Prior to Discharge (up to Day 1 post-index procedure)",{"measure":33,"description":34,"timeFrame":35},"Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Questionnaire Score","The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding \"extremely\" difficult to all questions answered), while a score of 100 corresponds to no disability (or responding \"not at all\" limited, difficult or bothersome to all questions answered). A positive change in score corresponds to improvement in AF symptoms.","Baseline, up to 12 months post-index procedure",{"measure":37,"description":38,"timeFrame":17},"Total Procedure Time","Total procedure time will be reported.",{"measure":40,"description":41,"timeFrame":17},"Mapping Time","Mapping time will be reported.",{"measure":43,"description":44,"timeFrame":17},"Pulsed Field Ablation (PFA) Application Time","PFA application time will be reported.",{"measure":46,"description":47,"timeFrame":17},"Number of PFA Ablation","Number of PFA ablation will be reported.",{"measure":49,"description":50,"timeFrame":17},"Total Fluoroscopy Time","Total fluoroscopy time will be reported.",{"measure":52,"description":53,"timeFrame":17},"Study Catheter Dwell Time","Dwell time is defined as time from first Varipulse catheter insertion in LA until removal from LA.",{"measure":55,"description":56,"timeFrame":17},"Ablation Settings Used","The ablation parameters setting used for the procedure will be reported.",{"measure":58,"description":59,"timeFrame":17},"Use of Paralytics and Anesthesia, and Related Drug Details","Number of participants reporting the use of paralytics and anesthesia, and related drug details will be reported.",null,{"allocation":60,"interventionModel":60,"interventionModelDescription":60,"primaryPurpose":60,"observationalModel":62,"timePerspective":63,"maskingInfo":60},"COHORT","PROSPECTIVE","The study population will include participants diagnosed with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF) or who are intolerable to class I and\u002For III antiarrhythmic drugs (AAD) based on medical records.",[66,69],{"label":67,"type":60,"description":68,"interventionNames":60},"General Anesthesia Group","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":70,"type":60,"description":71,"interventionNames":60},"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.",[73],{"name":74,"affiliation":5,"role":75},"Johnson & Johnson Medical (Shanghai) Ltd. Clinical Trial","STUDY_DIRECTOR",[77],{"name":78,"role":79,"phone":80,"phoneExt":81,"email":82},"YanTing Zhang","CONTACT","13162835013","+86","yzhan365@ITS.JNJ.com",{"type":84,"investigatorFullName":60,"investigatorTitle":60,"investigatorAffiliation":60,"oldNameTitle":60,"oldOrganization":60},"SPONSOR","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":96,"type":97},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).",[101],"Atrial Fibrillation","NOT_YET_RECRUITING","2026-06-04",{"date":105,"type":106},"2026-06-05","ACTUAL",{"date":108,"type":97},"2026-07-01",{"date":110,"type":97},"2028-03-28",{"name":5,"class":6}]