Atrial Fibrillation Management in Congestive Heart Failure With Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 20
- 主要终点
- Left ventricular ejection fraction (LVEF) by transthoracic echocardiography (TTE)
研究概览
简要总结
It is the purpose of the study to show the benefit of the endocardial catheter ablation by pulmonary vein isolation in patients with persistent or longstanding persistent atrial fibrillation, low LVEF and requiring ICD or CRT-D therapy compared to the best medical treatment with antiarrhythmic drugs.
详细描述
Atrial fibrillation is the most common sustained cardiac arrhythmia affecting 5% of people older than 65 years. It is associated with a 5 times increase of the risk of stroke in patients who are not receiving anticoagulant therapy and a doubling of the rate of death in all patients.
Congestive heart failure (CHF) and atrial fibrillation (AF) often co-exist, where one condition is promoting the development of the other and worsens its condition.
It is the purpose of the study to show the benefit of the endocardial catheter ablation by pulmonary vein isolation in patients with persistent (for a minimum of 1 week to a maximum of 1 year duration) or longstanding persistent (for a minimum of 1 year to a maximum of 4 years) atrial fibrillation, low LVEF (<=35%) and requiring ICD or CRT-D therapy compared to the best medical treatment with antiarrhythmic drugs.
Patients meeting the inclusion and exclusion criteria will be randomized in a 1:1 fashion in an unblinded, parallel arm treatment format to either drug therapy (directed at rate or rhythm control) or catheter ablation.
All therapies will be established and optimized in a 3 month treatment initiation phase (Blanking Period) starting with randomization. For all morbidity and mortality end-points, intention-to-treat analysis will begin at randomization. Efficacy with respect to AF treatment will be established for long-term follow up beginning after 3-month initiation phase.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having signed and dated Patient Informed Consent
- •Having an indication for ICD or CRT-D therapy as indicated by current valid guidelines or having been implanted with an ICD or CRT-D
- •Symptomatic atrial fibrillation (persistent AF (for a minimum of 1 week to a maximum of 1 year) or longstanding persistent AF (for a minimum of 1 year to a maximum of 4 years)) irrespective of the duration of paroxysmal AF
- •Ejection fraction ≤ 35% as assessed by transthoracic echocardiography
- •Left atrial diameter of less than 60 mm in parasternal diameter during transthoracic echocardiographic study
- •ECG documentation of atrial fibrillation (ECG, Holter, event recorders, etc) related to symptomatic episodes
- •Having typical symptoms of heart failure NYHA II - III
- •Patients > 30 days under optimal medical treatment for heart failure and CRT therapy in case of a pre-implanted CRT-D device
- •Age 18 - 75 years
- •Willing to participate in randomized trial
- •Willing and able to participate in 12 months follow-up period
排除标准
- •Longstanding persistent (> 4 years history) or paroxysmal atrial fibrillation
- •Having a previously implanted pacemaker
- •Having underlying valvular heart disease unless the disease has been corrected
- •Patients with acute myocardial infarction
- •Patients who have had previous pulmonary vein isolation procedures
- •Patients with atrial fibrillation secondary to a reversible cause
- •Known presence of intracardiac or other thrombi
- •Pregnant females or those of child bearing potential who have not had a negative pregnancy test within 48 hours before treatment
- •Patients with other medical condition (i.e., cancer, alcoholism, drug abuse) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than one year)
- •History of bleeding diathesis or suspected pro-coagulant state
- •Contraindication to anticoagulation therapy
研究组 & 干预措施
A
Best Medical Treatment, ICD/CRT implant
干预措施: ICD/CRT implant (Device)
A
Best Medical Treatment, ICD/CRT implant
干预措施: Best Medical Treatment (Other)
B
AF Ablation, ICD/CRT implant
干预措施: ICD/CRT implant (Device)
B
AF Ablation, ICD/CRT implant
干预措施: AF ablation (Procedure)
结局指标
主要结局
Left ventricular ejection fraction (LVEF) by transthoracic echocardiography (TTE)
时间窗: 12months
evaluated by Core Lab
次要结局
- Number of adequate and inadequate ICD interventions(12 months)
- Exercise capacity in 6 min walk test(12 months)
- AF burden(9 months)
- Recurrence of atrial tachyarrhythmia(9 months)
- Adverse events(12 months)
- Mortality(12 months)
- Quality of life(12 months)