Pulmonary Vein Isolation or Atrioventricular Node Ablation in Patients With Heart Failure and Symptomatic Atrial Fibrillation Diminishing CRT Response (PULVERISE-AF-CRT): a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- All-cause death.
研究概览
简要总结
Pulmonary vein isolation (PVI) is currently the cornerstone non pharmacological therapy for drug-refractory atrial fibrillation (AF). Where rhythm control has been shown to be inferior as compared to rate control in older trials. New data suggest that for patients with heart failure and AF PVI may improve prognosis (mortality) as compared to medical rate or rhythm control. Whether optimal rate control as can be achieved with atrioventricular node ablation is comparable with regard to all-cause mortality of heart failure hospitalization to PVI in patients with heart failure and AF is unknown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Presence of a cardiac resynchronization therapy device (CRT-D or CRT-P) and optimal medical therapy according to current guidelines.
- •Patients with paroxysmal or persistent AF, having AF or HF related symptoms.
- •Patient with paroxysmal AF should have >25% burden or inadequate biventricular pacing (<95%) based on device counters.
- •The patient is willing and able to comply with the protocol and has provided written informed consent.
- •Age ≥ 18 years
排除标准
- •Documented left atrial diameter > 6 cm (parasternal long axis).
- •Longstanding persistent AF longer than 2 years.
- •Contraindication to chronic anticoagulation therapy or heparin
- •Previous left heart ablation procedure for AF
- •Acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2 months prior to enrolment
- •Untreated hypothyroidism or hyperthyroidism
- •Enrolment in another investigational drug or device study.
- •Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age.
- •Mental or physical inability to participate in the study.
- •Listed for heart transplant.
- •Cardiac assist device implanted.
- •Planned cardiovascular intervention.
- •Life expectancy ≤ 12 months.
- •Uncontrolled hypertension.
- •Requirement for dialysis due to terminal renal failure.
- •Participation in another telemonitoring concept
结局指标
主要结局
All-cause death.
时间窗: 1 year
Occurence of all-cause death.
cardiovascular hospitalization.
时间窗: 1 year
Occurence of cardiovascular hospitalization (heart failure or stroke).
Quality of life
时间窗: 1 year
Change in quality of life (using the Kansas City Cardiomyopathy Questionnaire (KCCQ)).
次要结局
- Death from any cause(1 year)
- unplanned hospitalization for cardiovascular disease(1 year)
- changes in the Kansas city cardiomyopathy questionnaire(1 year)
- Unplanned hospitalization(1 year)
- Any hospitaliation(1 year)
- atrial fibrillation-free intervals were assessed.(1 year)
- death from cardiovascular disease(1 year)
- cerebrovascular accident.(1 year)
- procedure related adverse events(1 year)