NCT06499818尚未招募不适用
Circumferential Pulmonary Vein Isolation Alone Versus CPVI Plus Low-Voltage Areas Ablation During SR Versus CPVI Plus Low-Voltage Areas Ablation During AF for the Treatment of CAF
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- The incidence of no atrial arrhythmias greater than 30 seconds
研究概览
简要总结
The primary objective of this investigation is to compare the efficacy of Three different AF ablation strategies in patients with Persistent atrial fibrillation: CPVI plus Low-Voltage Areas ablation during sinus rhythm Versus. CPVI Plus Low-Voltage Areas Ablation During AF and CPVI alone.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients age is 18-80 years;
- •Patients with non-paroxysmal AF; non-paroxysmal AF will be defined as a sustained episode lasting > 7 days;
- •Patients can sign the written informed consent for the study;
- •Patients can endure the required follow-up.
排除标准
- •Patients who had previously undergone atrial fibrillation, atrial tachycardia, or atypical atrial flutter ablation
- •Preoperative combined atrial tachycardia (≥30S) and atypical atrial flutter
- •Left atrial diameter >55mm
- •Left ventricular ejection fraction <35%
- •Left atrial thrombus
- •Postoperative cardiac surgery
- •After valve replacement
- •After permanent pacemaker implantation
- •hypertrophic cardiomyopathy
- •Patients with moderate-to-severe aortic valve disease, moderate-to-severe mitral stenosis, and severe other valvular disease
- •Hemorrhagic stroke within 6 months
- •Transient ischemic attack or ischemic stroke within 1 month
- •Mental disorder or history of mental illness and inability to cooperate voluntarily
- •Breastfeeding, pregnancy and women planning or likely to become pregnant
- •Life expectancy <12 months
- •Participating in other interventional clinical trials
- •The researchers judged that it was not suitable for inclusion in this study
结局指标
主要结局
The incidence of no atrial arrhythmias greater than 30 seconds
时间窗: at least 18 months follow up
The incidence of no atrial arrhythmias greater than 30 seconds
次要结局
- No use of antiarrhythmic drugs and no occurrence of atrial tachycardia/flutter exceeding 30 seconds(at least 18 months follow up)
- Atrial fibrillation load(at least 18 months follow up)
- No use of antiarrhythmic drugs and no occurrence of atrial fibrillation exceeding 30 seconds(at least 18 months follow up)
- Procedure time(Surgical procedure)
- Ablation time(1 week after patient enrollment)
- Incidence of peri-procedural complications(at least 18 months follow up)
研究者
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