[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659437":3},{"organization":4,"outcomesModule":7,"designInfo":60,"detailedDescription":59,"studyPopulation":59,"armGroups":68,"interventions":81,"overallOfficials":59,"centralContacts":91,"locations":101,"responsibleParty":114,"collaborators":59,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":59,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":59,"enrollmentInfo":127,"targetDuration":59,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":59,"overallStatus":140,"whyStopped":59,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Tianjin Medical University General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":59},[9,13],{"measure":10,"description":11,"timeFrame":12},"Freedom from atrial arrhythmia recurrence at 12 months","Percentage of participants free from documented atrial arrhythmias (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting \\>30 seconds at 12 months post-ablation.","12 months post-procedure",{"measure":14,"description":15,"timeFrame":16},"Incidence of major procedure-related complications","Incidence of major adverse events related to the procedure, such as cardiac tamponade, thromboembolic events, vascular complications, pulmonary vein stenosis, and phrenic nerve injury.","Within 12 months post-procedure",[18,22,25,28,31,34,37,40,43,46,50,53,56],{"measure":19,"description":20,"timeFrame":21},"Change in left atrial volume index (LAVI)","Change from baseline in left atrial volume index (LAVI) at each follow-up visit.","Baseline to 12 months post-procedure",{"measure":23,"description":24,"timeFrame":21},"Change in left ventricular ejection fraction (LVEF)","Change from baseline in left ventricular ejection fraction (LVEF) at each follow-up visit.",{"measure":26,"description":27,"timeFrame":21},"Change in mitral inflow E\u002FA ratio","Change from baseline in E\u002FA ratio at each follow-up visit.",{"measure":29,"description":30,"timeFrame":21},"Change in left atrial reservoir strain (LASr)","Change from baseline in LASr at each follow-up visit.",{"measure":32,"description":33,"timeFrame":21},"Change in tissue Doppler a'\u002Fe' ratio","Change from baseline in a'\u002Fe' ratio at each follow-up visit.",{"measure":35,"description":36,"timeFrame":21},"Change in left atrial conduit strain (LAScd)","Change from baseline in LAScd at each follow-up visit.",{"measure":38,"description":39,"timeFrame":21},"Change in left atrial contractile strain (LASct)","Change from baseline in LASct at each follow-up visit.",{"measure":41,"description":42,"timeFrame":21},"Change in quality of life score","Change from baseline in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) health-related quality of life questionnaire score. The scale consists of five dimensions (mobility, self-care, usual activities, pain\u002Fdiscomfort, anxiety\u002Fdepression). The minimum score for each dimension is 1 (no problems) and the maximum score is 5 (unable to\u002Fextreme problems), with a total score range of 5 to 25. Higher scores indicate a worse health-related quality of life outcome.",{"measure":44,"description":45,"timeFrame":21},"Change in myocardial injury markers (troponin)","Change from baseline in troponin at different time points.",{"measure":47,"description":48,"timeFrame":49},"Change in inflammatory markers (CRP)","Change from baseline in C-reactive protein (CRP) at different time points.","From the initial assessment to 12 months after the procedure",{"measure":51,"description":52,"timeFrame":21},"Change in inflammatory markers (IL-6)","Change from baseline in interleukin-6 (IL-6) at different time points.",{"measure":54,"description":55,"timeFrame":21},"Change in fibrosis markers (Galectin-3)","Change from baseline in Galectin-3 at different time points.",{"measure":57,"description":58,"timeFrame":21},"Change in fibrosis markers (sST2)","Change from baseline in soluble ST2 (sST2) at different time points.",null,{"allocation":61,"interventionModel":62,"interventionModelDescription":59,"primaryPurpose":63,"observationalModel":59,"timePerspective":59,"maskingInfo":64},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":65,"maskingDescription":59,"whoMasked":66},"SINGLE",[67],"OUTCOMES_ASSESSOR",[69,75],{"label":70,"type":71,"description":72,"interventionNames":73},"PFA Group","EXPERIMENTAL","Patients will be treated with the novel Pulsed Field Ablation system",[74],"Device: Novel Pulsed Field Ablation System",{"label":76,"type":77,"description":78,"interventionNames":79},"RFCA Group","ACTIVE_COMPARATOR","Patients will be treated with conventional radiofrequency catheter ablation.",[80],"Device: Radiofrequency Ablation Catheter",[82,87],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":59},"DEVICE","Novel Pulsed Field Ablation System","Use a novel PFA system (YTL-PFA01) and a three-dimensional electroanatomical mapping system to perform pulmonary vein isolation.",[70],{"type":83,"name":88,"description":89,"armGroupLabels":90,"otherNames":59},"Radiofrequency Ablation Catheter","Use conventional radiofrequency ablation catheters to perform pulmonary vein isolation.",[76],[92,97],{"name":93,"role":94,"phone":95,"phoneExt":59,"email":96},"Heng Cai, Master","CONTACT","+86 13821378394","yuong1101@163.com",{"name":98,"role":94,"phone":99,"phoneExt":59,"email":100},"Xue Li","+86 13752697996","xuelizyy@tmu.edu.cn",[102],{"facility":5,"status":59,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":59},"Tianjin","Tianjin Municipality","300052","China","CN",{"type":109,"coordinates":110},"Point",[111,112],117.17667,39.14222,{"lat":112,"lon":111},{"type":115,"investigatorFullName":116,"investigatorTitle":117,"investigatorAffiliation":5,"oldNameTitle":59,"oldOrganization":59},"PRINCIPAL_INVESTIGATOR","Heng Cai","Chief Physician","100659437","pulsed-field-ablation-for-paroxysmal-atrial-fibrillation-clinical-efficacy-and-left-atrial-function-protection-100659437",false,"NCT07865221","Pulsed Field Ablation for Paroxysmal Atrial Fibrillation: Clinical Efficacy and Left Atrial Function Protection","Clinical Application Evaluation of a Novel Pulsed Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation and Its Protective Effect on Left Atrial Function","Inclusion Criteria:\n\n1. Age \\>= 18 years.\n2. Symptomatic paroxysmal atrial fibrillation (AF duration \\\u003C 7 days).\n3. Ineffective treatment with one or more antiarrhythmic drugs (e.g., propafenone, sotalol, amiodarone).\n4. Discontinued antiarrhythmic drugs for at least 5 half-lives before the procedure.\n5. Willing to receive PFA treatment and postoperative follow-up, and able to sign informed consent.\n\nExclusion Criteria:\n\n1. Previous radiofrequency catheter ablation (RFCA) for atrial fibrillation.\n2. Presence of a cardiac pacemaker or post-left atrial appendage closure.\n3. Thrombocytopenia (PLT \\\u003C 80×10\\^9\u002FL) or contraindications to anticoagulation (e.g., warfarin, heparin, direct factor Xa inhibitors, direct thrombin inhibitors).\n4. Left atrial anterior-posterior diameter \\> 55 mm (by transthoracic echocardiography, parasternal long-axis view).\n5. Left atrial (or left atrial appendage) thrombus (confirmed by TEE or MSCT).\n6. Severe structural heart disease (e.g., hypertrophic obstructive cardiomyopathy, severe valvular heart disease) or uncontrolled heart failure (NYHA class III or IV).\n7. Thyroid dysfunction (e.g., uncontrolled hyperthyroidism).\n8. Severe hepatic or renal impairment (AST or ALT \\>= 3 times upper limit of normal; SCr \\> 3.5 mg\u002Fdl or Ccr \\\u003C 30 ml\u002Fmin).\n9. History of stroke within the past 6 months.\n10. History of surgery within the past 3 months.\n11. Pregnant women.\n12. Life expectancy \\\u003C 12 months.","ALL","18 Years",{"count":128,"type":129},220,"ESTIMATED","INTERVENTIONAL",[132],"NA","This is a prospective clinical study aiming to evaluate the clinical efficacy and safety of a novel domestic pulsed field ablation (PFA) system in the treatment of paroxysmal atrial fibrillation (PAF), and to specifically assess its protective effect on left atrial function.\n\nApproximately 200-220 patients with paroxysmal atrial fibrillation are planned to be enrolled. Participants will be treated with the novel PFA system (YTL-PFA01) and a three-dimensional electroanatomical mapping system.\n\nThe primary objectives include:\n\nEfficacy: Immediate pulmonary vein isolation success rate, and freedom from atrial arrhythmias (\\>30 seconds) at 12 months post-procedure.\n\nSafety: Incidence of major complications (such as cardiac tamponade, stroke, pulmonary vein stenosis, phrenic nerve palsy).\n\nLeft Atrial Function: Dynamic changes in echocardiographic parameters (e.g., LAVI, LVEF, E\u002FA, LASr\u002Fcd\u002Fct) and serum biomarkers (e.g., troponin, BNP, inflammatory markers) at multiple time points before and after the procedure.\n\nPatients will be followed up for 12 months to evaluate the long-term outcomes and quality of life improvement (EQ-5D-5L). The study duration is expected to be 36 months (October 2025 to September 2028).",[135,136,137,138,139],"Paroxysmal Atrial Fibrillation","Pulsed Field Ablation","Catheter Ablation","Left Atrial Function","Cardiology","NOT_YET_RECRUITING","2026-10-08",{"date":143,"type":144},"2026-10-14","ACTUAL",{"date":146,"type":129},"2026-10",{"date":148,"type":129},"2028-10",{"name":5,"class":6},1]