Catheter ABlation of Atrial Fibrillation Versus Atrioventricular Nodal Ablation with CondUction System Pacing in Persistent Atrial Fibrillation and Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 19
- 主要终点
- Non-inferiority endpoint
研究概览
简要总结
The goal of this clinical trial is to evaluate two treatment strategies in patients with chronic atrial fibrillation and heart failure, who are eligible for atrial fibrillation ablation. Patients will be randomized to either atrial fibrillation ablation or to implantation of a pacemaker with conduction system pacing followed by atrioventricular node ablation. The effect of treatment allocation on total mortality, cardiovascular hospitalization and heart failure hospitalization will be compared.
详细描述
Aim To compare clinical outcome with a strategy of conduction system pacing and atrioventricular nodal ablation (CSP+AVNA), versus atrial fibrillation (AF) ablation by pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (AF) and heart failure (HF), to guide future management of these patients.
Hypotheses
- CSP+AVNA is superior to AF ablation in patients with persistent AF and HF for reducing mortality and cardiovascular hospitalization.
- CSP+AVNA is non-inferior to AF ablation in patients with persistent AF for reducing mortality and heart failure hospitalization.
Design Investigator-initiated, prospective randomized, controlled, open-label, multicentre study conducted in ~ 30 centres from 14 countries in Europe with expertise in CSP and AF ablation.
Sample size 220 patients
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(i) Persistent AF with symptomatic HF despite medical therapy, considered to be suitable for AF ablation, with at most one previous PVI procedure.
- •(ii) At least one prior hospital admission, or emergency room / HF clinic visit for HF in the past 2 years, with NT-pro-BNP > 1000 pg/ml or BNP > 250 pg/ml measured at any timepoint during this interval.
- •(iii) Previous or current rate or rhythm control drug therapy. (iv) Age > 60 years
排除标准
- •(i) NYHA Class IV and systolic blood pressure ≤80 mmHg despite optimized therapy.
- •(ii) Life expectancy < 2 years. (iii) Need for major surgical intervention. (iv) Myocardial infarction, stroke or PCI within the previous 3 months. (v) Previously implanted or planned implantation of CRT device or pacemaker. Implantable cardioverter defibrillator (ICD) implantation without a pacing indication is acceptable.
- •(vi) Participation in another controlled trial. (vii) Inability to sign and informed consent form.
结局指标
主要结局
Non-inferiority endpoint
时间窗: 1-4 years
Incidence of mortality and heart failure hospitalization in each arm
Superiority endpoint
时间窗: 1-4 years
Incidence of mortality and cardiovascular hospitalization in each arm
次要结局
- NYHA class(1-4 years)
- Cost-Effectiveness Analysis(1-4 years)
- Left ventricular ejection fraction(1 year)
- Minnesota Living with Heart Failure quality of life measure(1 year)
- Complications(1-4 years)
研究者
Haran Burri, MD
Chief Investigator and Sponsor Representative
University Hospital, Geneva