A Pilot Randomized Trial of Hybrid Persistent Atrial Fibrillation Ablation in Heart Failure CONVERGE-HF
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Composite of Major Adverse Event Rate after blanking period post procedure
研究概览
简要总结
Pilot, randomized, unblinded, feasibility and proof of concept clinical trial randomizing 50 patients in a 1:1 ratio to hybrid ablation or catheter ablation
详细描述
To determine if a hybrid convergent ablation procedure with atrial appendage clip is superior to catheter ablation in the management of heart failure patients with persistent and longstanding persistent AF.
Hypothesis
Hybrid convergent ablation procedure with atrial appendage clip is superior to catheter ablation in the management of heart failure patients with persistent and longstanding persistent AF in terms of mortality and worsening heart failure, AF rhythm control and improvement in LVEF, quality of life, and 6-minute walk distance.
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
- •Subjects must meet all of the following criteria:
- •Be >18 years of age
- •Provide signed written Informed Consent
- •Persistent or longstanding persistent AF
- •Heart failure with LV systolic dysfunction (defined as EF<40%) and prior hospitalization for heart failure in the preceding 12 months (randomization will account for 2 strata >30% vs <30% to ensure balanced enrollment)
- •Moderate or severe left atrial enlargement (Left atrial diameter>45 mm and not exceeding 60 mm; or indexed LA volume >40 ml/m2 and not exceeding 110 ml/ m2)
- •Ability to complete 6 minute walk test
- •Negative pregnancy test for female patients of child bearing potential.
- •Be eligible for ablation and anti-arrhythmic drugs
排除标准
- •Subjects must meet none of the criteria:
- •Very severe left atrial enlargement with diameter >60 mm or indexed LA Volume >110 mL/m2
- •Stroke or myocardial infarction within the preceding 3 months
- •Reversible causes of AF such as pericarditis, thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
- •Presently with Valvular Heart disease requiring surgical intervention
- •Presently with coronary artery disease requiring surgical or percutaneous intervention
- •Early Post-operative AF (within three months of surgery)
- •History of AVN ablation
- •Liver Failure
- •Renal Failure requiring dialysis
- •Social factors that would preclude follow up or make compliance difficult.
- •Contraindication to the use of appropriate anticoagulation therapy
- •Enrollment in another investigational drug or device study.
- •Patients with severe pulmonary disease
- •Documented intra-atrial thrombus, tumor, or another structural abnormality which precludes ablation
结局指标
主要结局
Composite of Major Adverse Event Rate after blanking period post procedure
时间窗: Up to 2 years
Major Adverse Events consist of death from cardiovascular causes, worsening of heart failure defined as hospitalization, visits for IV diuresis or escalation to advanced heart failure therapies; need for continuation of AADs or redo ablation for recurrent arrhythmias beyond the blanking period.
次要结局
- Change in distance walked in 6-minute walk test(up to 2 years)
- Total number of cardiovascular hospitalizations(Up to 2 years)
- Change in MLHF Quality of Life(up to 2 years)
- Change in EF during trial period(up to 2 years)
- Cerebrovascular accidents(up to 2 years)
- Death from cardiovascular causes(up to 2 years)
- Redo ablation beyond the blanking period(3 month post procedure up to 2 years)
- Recurrence of AF lasting more than 30 seconds(Up to 2 years)
- All-cause mortality(up to 2 years)
- AF burden(up to 2 years)
- Worsening of Heart Failure(up to 2 years)
- Need for continuation of Antiarrhythmic drug(s) beyond the blanking period(3 month post procedure up to 2 years)
- Unplanned hospitalization due to cardiovascular reasons(up to 2 years)
- Worsening heart failure requiring unplanned hospitalization or escalation to advanced heart failure therapies(up to 2 years)