[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578911":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":11,"responsibleParty":39,"collaborators":11,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":11,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":68,"whyStopped":11,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":11},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CTI-alone arm","ACTIVE_COMPARATOR",null,[13],"Procedure: Cavo-tricuspid isthmus ablation",{"label":15,"type":16,"description":11,"interventionNames":17},"CTI+CPVI Arm","EXPERIMENTAL",[18],"Procedure: Pulmonary vein isolation plus cavo-tricuspid isthmus ablation",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"PROCEDURE","Pulmonary vein isolation plus cavo-tricuspid isthmus ablation","For those who are randomized to CTI+CPVI Arm, additional CPVI should be performed after finishing CTI ablation. CPVI could be performed using open-irrigated contact-force catheter, cryoballoon catheter or pulse-field ablation catheter. The endpoint is defined as both entrance and exit block in the pulmonary veins.",[15],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Cavo-tricuspid isthmus ablation","In periprocedural period, all antiarrhythmic drugs were discontinued for at least 5 half-lives and amiodarone for 2 months before the procedure. An electrophysiological study was performed after overnight fasting and mild sedated state with administration of intravenous midazolam and fentanyl.\n\nCTI ablation should be performed under the CARTO or Ensite electroanatomic mapping system using an open-irrigated contact-force ablation catheter. Radiofrequency should be delivered at 30-50 W with a contact-force between 5-30 g in a point-by-point fashion until the CTI line is completed. Touch-up radiofrequency should be performed as needed. The endpoint of ablation is termination of AFL, if present, and the demonstration of bidirectional block across the CTI by using differential pacing.",[9],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Youmei Shen, M.D.","CONTACT","+86-15720801576","symnjmu@163.com",{"name":36,"role":32,"phone":37,"phoneExt":11,"email":38},"Hailei Liu, M.D.","+86-18094226858","liuhailei@njmu.edu.cn",{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Minglong Chen","Dr.","100578911","pulmonary-vein-isolation-in-typical-atrial-flutter-and-heart-failure-100578911",false,"NCT06817447","Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure","Prophylactic Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure: a Prospective, Multi-center, Randomized Controlled Study","PVI-AFL-HF","Inclusion Criteria:\n\n* Aged 18 to 80 years\n* Typical AFL referring for ablation\n* No prior history of AF\n* Fulfilling the criteria for HF: New York Heart Association (NYHA) function class II or greater; and N-terminal pro-brain natriuretic peptide (NT-pro-BNP) \\>125 pg\u002Fml in sinus rhythm or \\>365 pg\u002Fml in AFL\n* Optimized guideline-directed medical therapy for HF for at least one month\n* A minimum of anticoagulation for three weeks\n* Sign informed consent\n\nExclusion Criteria:\n\n* Any AF episodes documented during 48-hour Holter monitoring\n* Presence of left atrial thrombus\n* HF due to infiltrative cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or uncorrected primary valvular disease\n* Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment\n* Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease\n* Untreated hypothyroidism or hyperthyroidism\n* Dialysis-dependent terminal renal failure\n* Life expectancy \\\u003C12 months due to non-cardiovascular causes.\n* Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study\n* Female under pregnancy or breast-feeding\n* Involved in other studies","ALL","18 Years","80 Years",{"count":55,"type":56},168,"ESTIMATED","INTERVENTIONAL",[59],"NA","This study, called the PVI-AFL-HF Trial, investigates two treatments for patients with typical atrial flutter (AFL) and heart failure (HF). It aims to determine whether adding prophylactic pulmonary vein isolation (CPVI) to the standard cavo-tricuspid isthmus (CTI) ablation improves long-term outcomes compared to CTI ablation alone.",[62,63],"Atrial Flutter Typical","Heart Failure",[65,66,67],"atrial flutter","Heart failure","Pulmonary vein isolation","NOT_YET_RECRUITING","2025-02-05",{"date":71,"type":72},"2025-02-10","ACTUAL",{"date":74,"type":56},"2025-03-01",{"date":76,"type":56},"2029-03-01",{"name":5,"class":6}]