Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Atrial Fibrillation Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of stroke
研究概览
简要总结
Cryoablation combined with left atrial appendage closure is a novel strategy for atrial fibrillation patients. Through long-term follow-up, the investigators aimed to observe the safety and efficacy of the combined procedure in Chinese population.
详细描述
the investigators aimed to observe the clinical outcome of combining cryoballoon ablation (CBA) with left atrial appendage closure (LAAC) in drug-refractory non-valvular atrial fibrillation patients, who have high risk of stroke or hemorrhage, or contraindication of long-term oral anticoagulants (OACs).
The combined procedure was completed using CBA following LAAC. Generally, 3-month OACs, following 3-month double antiplatelet therapy, and lifelong single platelet therapy was recommended as antithrombotic regimen.
At 3rd,6th,12th and every year after since the procedure, Holter and transoesophageal echocardiography monitoring, and outpatient follow-up was applied to every patient.
The safety was evaluated by all-cause mortality, peri- and postprocedural complications. While the efficacy was evaluated through the freedom of atrial arrhythmia, stroke incidence, and withdrawal of OACs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •CHA2DS2-VASc score≥2 or HAS-BLED score≥3,
- •having contraindications to long-term oral anticoagulants (OACs),
- •refuse OAC therapy despite explanation.
排除标准
- •thrombus in left atrium (LA) or left atrial appendage (LAA) presented and confirmed by transoesophageal echocardiograph (TEE),
- •oversized LA (LA diameter>65mm by TTE) or LAA (LAA opening>35mm) through TEE,
- •pericardial effusion (≥4mm by TTE or TEE),
- •hemodynamic unstable patients,
- •patients with active hemorrhagic diseases,
- •ischemic or hemorrhagic stroke within 30 days.
结局指标
主要结局
Incidence of stroke
时间窗: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
the proportion of patients have either hemorrhagic or ischemic stroke confirmed by CT or MRI.
Recurrence of atrial arrhythmia
时间窗: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
The proportion of patients have recurrent atrial arrhythmia, including atrial tachycardia lasting longer than 30 seconds, atrial flutter, and atrial fibrillation. Detected by either ECG or 24 Holter monitor.
次要结局
- All-cause death(since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.)
- Redo-ablation(since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.)
- Pericardial effusion(Since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.)
- Rehospitalization due to cardiovascular events(Since the start of the procedure to 5 years.)
- Residual flow(Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result.)
- LAAC device position(Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result.)
- Cardiovascular death(since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.)
- Major hemorrhagic events(since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.)
- Myocardial infarction(since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.)
- Peripheral vascular embolism(since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.)
- Withdrawal of oral anticoagulants(since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.)
- Device related thrombus(Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result.)
- Atrioesophageal fistula(Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result.)
研究者
Ya-Wei Xu
Chief physician
Shanghai 10th People's Hospital