[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"left-atrial-function\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:left-atrial-function":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"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":19,"type":20},220,"ESTIMATED","INTERVENTIONAL",[23],"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).",[26,27,28,29,30],"Paroxysmal Atrial Fibrillation","Pulsed Field Ablation","Catheter Ablation","Left Atrial Function","Cardiology","NOT_YET_RECRUITING","2026-10-08",{"date":34,"type":35},"2026-10-14","ACTUAL",{"date":37,"type":20},"2026-10",{"date":39,"type":20},"2028-10",{"name":41,"class":42},"Tianjin Medical University General Hospital","OTHER"]