Pulmonary-vein Isolation or Ablation of Atrioventricular-node and Pacemaker Implantation for Elderly Patients With Persistent Atrial Fibrillation (ABLATE Versus PACE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 196
- 试验地点
- 20
- 主要终点
- Number of subjects with any hospitalization due to atrial fibrillation, atrial tachycardia or flutter after blanking period or cardiac decompensation requiring inpatient treatment
研究概览
简要总结
As patients age, symptom control and treatment of atrial fibrillation become equally difficult, often leading to increased hospitalization. ABLATE versus PACE is a prospective, randomized clinical trial comparing pacemaker implantation with AV node ablation with pulmonary vein isolation in terms of rehospitalization and quality of life in patients with persistent AF aged 75 years and older.
详细描述
Atrial fibrillation is the most common cardiac arrhythmia and is a major public and represents a major public health problem with increasing healthcare costs and increased mortality risk.
In case of recurrent symptomatic atrial fibrillation current guidelines recommend pulmonary-vein isolation (PVI) as invasive treatment option. However, 5-year arrhythmia-free survival estimate is 29% after single catheter ablation. Although the long-term success rates in maintaining sinus rhythm are higher than with drug-based rhythm control, they are still moderate, especially in older patients with comorbidities. Therefore, repeated interventions are often necessary.
An effective method for frequency control is atrioventricular (AV) node ablation after implantation of a pacemaker ("ablate-and-pace"). In this case, the ventricular rate is only set by the pacemaker and can be programmed according to the patient's needs.
There are some theoretical disadvantages of this treatment option (pacemaker dependency, reduction of cardiac outpout due to lack of atrial contraction) which is why this method nowadays is almost exclusively used in older (and physically less active) patients.
The ABLATE versus PACE trial is a prospective randomized clinical trial comparing at 196 these two treatment options in terms of rehospitalizations due to cardiovascular causes and quality of life in elderly patients (≥ 75 years) with normal ejection fraction (≥ 50%).
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
- 75 Years 至 99 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent AF according to current ESC guideline (2020)
- •Symptoms EHRA classification II - IV despite guideline indicated medical therapy
- •Age ≥ 75 years
- •Capability of giving written informed consent
排除标准
- •impaired systolic left ventricular function (ejection fraction < 50%)
- •High-grade (III°) left cardiac valvular disease
- •pre-implanted pacemaker
- •bradycardia-indication for pacemaker
- •Surgical coronary revascularization (within the last 90 days) or current triple therapy after stent PCI
- •contraindication for PVI or pacemaker-implantation
- •contraindication for oral anticoagulation
- •body-mass-index BMI > 40 kg/m2
- •inability to give written informed consent
- •concomitant participation in another registered trial
- •life expectancy < 12 months
- •reversible cause of AF (e.g. thyrotoxicosis, alcohol ingestion)
结局指标
主要结局
Number of subjects with any hospitalization due to atrial fibrillation, atrial tachycardia or flutter after blanking period or cardiac decompensation requiring inpatient treatment
时间窗: 36 months
except for protocol-indicated AVN ablation
Number of subjects requiring upgrade to cardiac resynchronization therapy pacemaker due to reduced systolic left ventricular function with ejection fraction ≤35% in "ablate-and-pace" group
时间窗: 36 months
Number of subjects requiring repeat ablation, electrical or pharmacological cardioversion for symptomatic relapse of atrial fibrillation, atrial tachycardia or flutter after blanking period
时间窗: 36 months
次要结局
- Number of subjects with nonfatal or fatal stroke/ transient ischemic attack (TIA)(36 months)
- Deterioration of systolic LV function ≥10 percent(36 months)
- Number of subjects with procedure-associated complications(36 months)
- Death from any cause(36 months)
- Quality of life as assessed by Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT)(36 months)
- Number of subjects requiring anti-arrhythmic drug treatment after initial ablation(36 months)
- Number of subjects requiring repeat ablation(36 months)
- Number of nights spent in hospital for occurrence of primary or secondary endpoints(36 months)