NCT06817447尚未招募不适用
Prophylactic Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure: a Prospective, Multi-center, Randomized Controlled Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 168
- 主要终点
- Composite endpoint of worsening heart failure requiring unplanned hospitalizations or urgent visits, and cardiovascular death
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Follow-up physicians are blinded to treatment allocation
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 80 years
- •Typical AFL referring for ablation
- •No prior history of AF
- •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/ml in sinus rhythm or >365 pg/ml in AFL
- •Optimized guideline-directed medical therapy for HF for at least one month
- •A minimum of anticoagulation for three weeks
- •Sign informed consent
排除标准
- •Any AF episodes documented during 48-hour Holter monitoring
- •Presence of left atrial thrombus
- •HF due to infiltrative cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or uncorrected primary valvular disease
- •Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment
- •Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease
- •Untreated hypothyroidism or hyperthyroidism
- •Dialysis-dependent terminal renal failure
- •Life expectancy <12 months due to non-cardiovascular causes.
- •Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
- •Female under pregnancy or breast-feeding
- •Involved in other studies
研究组 & 干预措施
CTI-alone arm
Active Comparator
干预措施: Cavo-tricuspid isthmus ablation (Procedure)
CTI+CPVI Arm
Experimental
干预措施: Pulmonary vein isolation plus cavo-tricuspid isthmus ablation (Procedure)
结局指标
主要结局
Composite endpoint of worsening heart failure requiring unplanned hospitalizations or urgent visits, and cardiovascular death
时间窗: From randomization until completion of the planned follow-up, assessed up to 48 months
次要结局
- Change in N-terminal pro-B type natriuretic peptide (NT-proBNP) at one-year(One-year)
- Time to hospitalization or urgent visits for heart failure(From randomization until completion of the planned follow-up, assessed up to 48 months)
- Time to hospitalization for heart failure(From randomization until completion of the planned follow-up, assessed up to 48 months)
- Time to change of diuretics(From randomization until completion of the planned follow-up, assessed up to 48 months)
- Time to urgent visits for heart failure(From randomization until completion of the planned follow-up, assessed up to 48 months)
- Change in New York Heart Association (NYHA) class at one-year(One-year)
- Time to cardiovascular death(From randomization until completion of the planned follow-up, assessed up to 48 months)
- Time to atrial fibrillation recurrence(From randomization until completion of the planned follow-up, assessed up to 48 months)
- Time to all-cause death(From randomization until completion of the planned follow-up, assessed up to 48 months)
- Change in quality of life - Kansas City Cardiomyopathy Questionnaire score (KCCQ-23) at one-year(One-year)
- Change in 6-minute walk test at one-year(One-year)
研究者
Minglong Chen
Dr.
The First Affiliated Hospital with Nanjing Medical University
相似试验
已完成
不适用
Comparing Pulmonary Vein Isolation to Pulmonary Vein Isolation + OPTIMA Ablation in Patients Undergoing Ablation for Atrial FibrillationAtrial Fibrillation ChronicNCT04101539Johns Hopkins University67
已完成
不适用
Comparison of Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force DataPulmonary Vein IsolationAtrial Fibrillation AblationAtrial FibrillationNCT01730924Queen Mary University of London120
进行中（未招募）
4 期
SINGLE SHOT CHAMPIONParoxysmal Atrial FibrillationNCT05534581Insel Gruppe AG, University Hospital Bern210
已完成
不适用
Comparison of Pulmonary Vein Isolation Versus AV Nodal Ablation With Biventricular Pacing for Patients With Atrial Fibrillation With Congestive Heart Failure (PABA CHF)Congestive Heart FailureAtrial FibrillationNCT00599976Azienda Policlinico Umberto I81
已完成
4 期
Trigger- vs. Substrate-Ablation for Paroxysmal Atrial FibrillationAtrial FibrillationNCT00196183Deutsches Herzzentrum Muenchen98