A Randomized Controlled Trial of Atrioventricular (AV) Junction Ablation and Biventricular Pacing Versus Optimal Pharmacological Therapy in Patients With Permanent Atrial Fibrillation
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,830
- 试验地点
- 1
- 主要终点
- Combined end-point
研究概览
简要总结
There is evidence of superiority of AV junction ablation strategy over pharmacological therapy only for symptoms of atrial fibrillation, but not for heart failure, hospitalization, morbidity and mortality. Hypothesis of trial is that AV junction ablation is superior to pharmacological therapy as regard hospitalization and mortality
详细描述
Prospective randomized, controlled, investigator-initiated trial which consists of two specific consecutive(overlapped) phases:
"Morbidity trial" (APAF-CRT morbidity). Small size (280 pts), follow-up 24 months. Primary endpoint: combined of mortality due to heartfailure, hospitalization for heart failure or atrial fibrillation or worsening heart failure. Predefined subgroup analysis for patients with ejection fraction ≤35% versus >35%
"Mortality trial" (APAF-CRT mortality). Large size (pts included in morbidity trial plus additional ~1500 pts, long-term follow-up (at least 4 years). Primary endpoint: total mortality. Predefined subgroup analysis for patients with ejection fraction ≤35% versus >35%
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible, each patient must be in the following condition:
- •Permanent atrial fibrillation (>6 months) which has been considered unsuitable for ablation or failed ablation
- •Narrow QRS ≤ 110 ms
- •Severely symptomatic (atrial fibrillation-related symptoms), refractory to drug therapy for rate control
- •At least one hospitalization related to atrial fibrillation and/or heart failure in the previous year (see definition below)
排除标准
- •New York Heart Association (NYHA) class IV and systolic blood pressure <80 mmHg despite optimized therapy;
- •severe concomitant non-cardiac disease;
- •need for surgical intervention;
- •myocardial infarction within the previous 3 months;
- •previous implanted devices (PM/ICD/CRT)
研究组 & 干预措施
Drug therapy
Control Arm: optimized drug therapy (plus implantable defibrillator (ICD) according to guidelines)
干预措施: Optimized drug therapy (Drug)
Drug therapy
Control Arm: optimized drug therapy (plus implantable defibrillator (ICD) according to guidelines)
干预措施: ICD (Device)
Device: AV junction ablation & CRT
AV junction ablation + CRT (CRT-P or CRT-D according to guidelines) + optimized drug therapy
干预措施: AV junction ablation (Procedure)
Device: AV junction ablation & CRT
AV junction ablation + CRT (CRT-P or CRT-D according to guidelines) + optimized drug therapy
干预措施: CRT (Device)
Device: AV junction ablation & CRT
AV junction ablation + CRT (CRT-P or CRT-D according to guidelines) + optimized drug therapy
干预措施: Optimized drug therapy (Drug)
Device: AV junction ablation & CRT
AV junction ablation + CRT (CRT-P or CRT-D according to guidelines) + optimized drug therapy
干预措施: ICD (Device)
结局指标
主要结局
Combined end-point
时间窗: Upto 3 years
"Morbidity trial" end-points Primary end-point: a combined of (1) mortality due to heart failure, (2) hospitalization for heart failure or uncontrolled intolerable atrial fibrillation, or (3) worsening heart failure
次要结局
- Major clinical events(Up to 5 years)