Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,420
- 试验地点
- 2
- 主要终点
- Primary Outcome Measures (Number of recurrence)
研究概览
简要总结
The combination of atrial fibrillation (AF) and heart failure (HF) is common and implies a poor prognosis. Pulmonary vein isolation is an established method for the treatment of symptomatic AF in patients with normal heart function and has been shown to be more effective than drug therapy. Recently, radiofrequency ablation has shown a positive effect in patients with AF and HF. POLAR-HF has been designed to investigate efficacy and safety of cryoballoon pulmonary vein isolation in patients with paroxysmal or persistent AF and severe HF (LVEF ≤ 40%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic paroxysmal or persistent atrial fibrillation
- •Patients with severe heart failure (LVEF ≤40%, assigned to heart failure group)
- •Patients with normal cardiac function (assigned to control group)
- •Age > 18 years
- •Consent capacity
排除标准
- •Age under 18 years
- •Pregnancy
- •Lack of consent capacity
结局指标
主要结局
Primary Outcome Measures (Number of recurrence)
时间窗: 60 months
Number of subjects with recurrence of atrial fibrillation, atrial flutter, atrial tachycardia or re-ablation after a blanking Period of 90 days after the initial cryoablation procedure
Primary Outcome Measures (number of safety events)
时间窗: 60 months
2\. Number of subjects with a primary safety event including a composite of death from any cause, stroke or transient ischemic attack and serious procedure-related adverse events (Major Bleeding by International Society on Thrombosis and Hemostasis (ISTH) criteria, pericardial effusion, cerebrovascular or systemic embolism, phrenic paresis, major groin site complications requiring treatment)
Primary Outcome Measures (Number of recurrence)
时间窗: 60 months
Number of subjects with recurrence of atrial fibrillation, atrial flutter, atrial tachycardia or re-ablation after a blanking Period of 90 days after the initial cryoablation procedure
Primary Outcome Measures (number of safety events)
时间窗: 60 months
2\. Number of subjects with a primary safety event including a composite of death from any cause, stroke or transient ischemic attack and serious procedure-related adverse events (Major Bleeding by International Society on Thrombosis and Hemostasis (ISTH) criteria, pericardial effusion, cerebrovascular or systemic embolism, phrenic paresis, major groin site complications requiring treatment)
次要结局
- Secondary Outcome Measures (number of deaths)(60 months)
- Secondary Outcome Measures (procedural success)(60 months)
- Secondary Outcome Measures (rehospitalization)(60 months)
- Secondary Outcome Measures (procedure duration)(60 months)
- Secondary Outcome Measures (total time)(60 months)
- Secondary Outcome Measures (total contrast use)(60 months)
- Secondary Outcome Measures (number of deaths)(60 months)
- Secondary Outcome Measures (procedural success)(60 months)
- Secondary Outcome Measures (rehospitalization)(60 months)
- Secondary Outcome Measures (procedure duration)(60 months)
- Secondary Outcome Measures (total time)(60 months)
- Secondary Outcome Measures (total contrast use)(60 months)