[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595785":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":50,"studyPopulation":50,"armGroups":57,"interventions":70,"overallOfficials":50,"centralContacts":80,"locations":86,"responsibleParty":101,"collaborators":50,"id":103,"slug":50,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":104,"sex":110,"minAge":111,"maxAge":50,"enrollmentInfo":112,"targetDuration":50,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":89,"whyStopped":50,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Hangzhou Dinova EP Technology Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"12-month atrial fibrillation (AF) ablation success rate","Defined as the absence of AF, atrial flutter (AFL), or atrial tachycardia (AT) episodes ≥30 seconds on dynamic electrocardiogram (ECG) monitoring after the blanking period (90 days post-catheter ablation)","12 months post-procedure",[14,18,22,26,30,33,36,40,43,47],{"measure":15,"description":16,"timeFrame":17},"Acute pulmonary vein ablation success rate","Defined as maintained bidirectional block across the ablation line 20 minutes after ablation","Immediately post-procedure",{"measure":19,"description":20,"timeFrame":21},"Incidence of major adverse events (MAEs) related to the device","Including stroke\u002Ftransient ischemic attack (TIA), pulmonary vein stenosis, phrenic nerve paralysis, systemic embolism, pericarditis, pericardial effusion\u002Fcardiac tamponade, atrioesophageal fistula, myocardial infarction, or severe vascular access complications","Within 7 days post-procedure",{"measure":23,"description":24,"timeFrame":25},"Incidence of repeat ablation","Summary ncidence of repeat ablation after the blanking period","Within 12 months post-procedure",{"measure":27,"description":28,"timeFrame":29},"AF burden","Record AF burden at 6 and 12 months post-procedure","6 and 12 months post-procedure",{"measure":31,"description":32,"timeFrame":25},"Incidence of cardiovascular MAEs","Incidence of thromboembolic events (including stroke\u002FTIA), cardiovascular-related rehospitalization, or cardiovascular mortality within 12 months post-procedure",{"measure":34,"description":35,"timeFrame":17},"Technical success rate of LAAC","Defined as successful LAA occlusion without residual shunt \\>3 mm and no device-related complications",{"measure":37,"description":38,"timeFrame":39},"LAA closure rate","Defined as imaging-confirmed residual shunt ≤3 mm at the device edges.","3 and 6 months post-procedure",{"measure":41,"description":42,"timeFrame":39},"Incidence of new residual shunt","Defined as any increase in residual shunt (post-procedure shunt volume - intraoperative shunt volume \\>0 mm)",{"measure":44,"description":45,"timeFrame":46},"Incidence of device-related thrombus","Record device-related thrombus events during follow-up","Within 12 months post-procedure.",{"measure":48,"description":49,"timeFrame":25},"Discontinuation rate of anticoagulants and antiarrhythmic medications","Record drugs history during follow up",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":50,"primaryPurpose":54,"observationalModel":50,"timePerspective":50,"maskingInfo":55},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":56,"maskingDescription":50,"whoMasked":50},"NONE",[58,64],{"label":59,"type":60,"description":61,"interventionNames":62},"CardiPulse Group","EXPERIMENTAL","Patients accept atrial fibrillation ablation with CardiPulse pulsed field ablation catheter",[63],"Device: CardiPulse",{"label":65,"type":66,"description":67,"interventionNames":68},"FaraPulse Group","ACTIVE_COMPARATOR","Patients accept atrial fibrillation ablation with FaraPulse pulsed field ablation catheter",[69],"Device: FaraPulse",[71,76],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":50},"DEVICE","CardiPulse","abc",[59],{"type":72,"name":77,"description":78,"armGroupLabels":79,"otherNames":50},"FaraPulse","bcd",[65],[81],{"name":82,"role":83,"phone":84,"phoneExt":50,"email":85},"Huimin Chu, Dorctor","CONTACT","+86 574-87085211","epnbheart@163.com",[87],{"facility":88,"status":89,"city":90,"state":50,"zip":50,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Ningbo First Hospital","RECRUITING","Hangzhou","China","CN",{"type":94,"coordinates":95},"Point",[96,97],120.16142,30.29365,{"lat":97,"lon":96},[100],{"name":82,"role":83,"phone":84,"phoneExt":50,"email":85},{"type":102,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100595785",false,"NCT07036965","Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation","Comparison of Different Pulsed Field Ablation Catheters Combined With Stroke Prevention in High Stroke Risk·Atrial Fibrillation: A Prospective, Multicenter, Randomized Controlled Trial","COMBINATION 2P","Inclusion Criteria:\n\n1. Older than 18 years.\n2. Diagnosed with drug-refractory, symptomatic atrial fibrillation.\n3. The patient has a high risk of stroke (CHA2DS2-VA score ≥ 2).\n4. Have a situation of:\n\n   1. requires oral anticoagulation therapy\n   2. high bleeding risk (HAS-BLED score ≥ 3) that unsuitable for or unwilling to undergo long-term oral anticoagulation therapy.\n5. Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.\n\nExclusion Criteria:\n\n1. History of persistent atrial fibrillation \\>1 year.\n2. Atrial fibrillation was secondary to thyroid disease or other reversible reasons.\n3. Left atrial anteroposterior diameter \\>50 mm.\n4. Evidence of left atrial or left atrial appendage thrombus on imaging examination.\n5. Concurrent other arrhythmias required for catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentrant tachycardia, pre-excitation syndrome) prior to enrollment.\n6. Rheumatic heart disease.\n7. Left ventricular ejection fraction \\\u003C40% or New York Heart Association (NYHA) class III\u002FIV.\n8. Unstable angina.\n9. Myocardial infarction (MI), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 3 months prior to enrollment.\n10. History of prior left atrial appendage closure, patent foramen ovale closure, atrial septal defect closure, or repair surgery.\n11. Implantation of a mechanical mitral valve prosthesis or metallic annuloplasty rings.\n12. Presence of intracardiac thrombus, space-occupying lesions, or other abnormalities that preclude vascular access or catheter manipulation.\n13. Contraindications to anticoagulation or history of coagulation disorders\u002Fabnormal bleeding.\n14. Active systemic infection.\n15. Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m² or history of renal dialysis.\n16. Pregnancy or breastfeeding.\n17. Life expectancy \\\u003C12 months (e.g., advanced malignancy).\n18. Current or anticipated participation in other drug or device clinical trials.\n19. Any other condition or abnormality deemed by the investigator to warrant exclusion.","ALL","118 Years",{"count":113,"type":114},292,"ESTIMATED","INTERVENTIONAL",[117],"NA","Pulsed field energy ablation, a non-thermal ablation modality, can potentially reduce post-ablation tissue edema. Previous studies have confirmed the feasibility and safety of combined pulsed field ablation (PFA) and left atrial appendage closure (LAAC) as a one-stop treatment, with few reports of post-ablation tissue edema. However, during PFA procedures, the presence of metallic components in the ablation site (e.g., occluder frames, metallic valves) may lead to arcing during energy delivery, compromising procedural safety. Therefore, when performing PFA+LAAC as a one-stop procedure, a \"ablation-first\" strategy is recommended. Due to the influence of parameters such as voltage, pulse width, and number of cycles on pulsed field energy characteristics, significant variability in ablation depth and area may exist between different PFA devices. To date, no large-scale clinical studies have compared the efficacy and safety of different PFA systems. Accordingly, this study will conduct a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of domestic versus imported pulsed field ablation catheters in the treatment of patients with atrial fibrillation.",[120],"Atrial Fibrillation (AF)",[122,123,124],"atrial fibrillation","pulsed field ablation","LAAC","2025-06-17",{"date":127,"type":128},"2025-06-25","ACTUAL",{"date":130,"type":114},"2025-06-30",{"date":132,"type":114},"2031-06-30",{"name":5,"class":6},1]