Effect of Cryoballoon Pulmonary Vein Isolation on Atrial Fibrillation Burden and Clinical Endpoints in Patients With Heart Failure With Impaired Left Ventricular Systolic Function
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 404
- 试验地点
- 1
- 主要终点
- Time to exceed AG burden cut-off of 1%
研究概览
简要总结
In this study 404 patients with heart failure and an ejection fraction of 0.40 or less, with paroxysmal atrial fibrillation, will be randomly assigned to standard treatment or standard treatment plus a session of cryoballoon ablation (left atrial balloon cryoablation for pulmonary vein isolation). All patients with either have an ICD or CRT-D/P device implanted or an implantable electrocardiographic monitoring device. The primary study endpoint will be the time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time).16 This AF burden corresponds to 7.2 hours per month.
A powered secondary endpoint will be the time to the composite of all-cause mortality and unplanned hospitalization for heart failure.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A minimum of at least two separate AF episodes recorded within the last 12 months, either on 12-lead rest ECG or on ambulatory ECG recordings (at least 5 minutes of AF on Holter recordings will be required),
- •LVEF <40% on sinus rhythm,
- •symptoms consistent with heart failure (New York Heart Association II or higher) despite rate control treatment,
- •age >21 years old.
排除标准
- •previous left atrial ablation,
- •left atrial diameter >28 mm/m2 BSA on TTE (parasternal long axis view),
- •strong clinical suspicion that reduced LVEF is primarily due to tachycardiomyopathy,
- •pre-existing device (ICD or CRT) without AF detection algorithms and/or (for CRT devices) diagnostics of effective biventricular pacing,
- •known primary electrical heart disease (e.g. Brugada syndrome),
- •presence of thrombus in a heart chamber,
- •presence of prosthetic valve at any position,
- •moderate/severe valvular heart disease,
- •active infectious disease or malignancy,
- •moderate or severe hepatic impairment (Child-Pugh class B or C),
- •severe renal failure (estimated glomerular filtration rate <20 ml/min/1.73 m2),
- •inability or unwillingness to adhere to standard treatment or to provide consent.
研究组 & 干预措施
Cryoballoon ablation
A 28-mm cryoballoon (Arctic Front Advance™ Cardiac CryoAblation Catheter, Medtronic, Minneapolis, MN) will be employed. The cryoballoon catheter will be introduced into the left atrium, following a single transeptal puncture, through a 12F FlexCath steerable sheath (Medtronic), constantly flushed with heparinized saline. A circular mapping catheter (Achieve, Medtronic) will be advanced through the cryoballoon to the PV orifice and positioned as proximally as possible inside the vessel to record the PV potentials at baseline and monitor the isolation procedure in real time.
干预措施: Cryoballoon ablation (Procedure)
Standard treatment
Standard treatment, including at least one rhythm control medication, on top of optimized rate control and HF treatment
结局指标
主要结局
Time to exceed AG burden cut-off of 1%
时间窗: Up to 2 years
The time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time)
次要结局
- All-cause mortality or hospitalization for heart failure(Up to 2 years)
研究者
Spyridon Deftereos
Professor of Cardiology
National and Kapodistrian University of Athens