Concomitant Hybrid Versus Catheter Ablation for Reinforcing Therapeutic Effect of Atrial Fibrillation With Hypertrophic Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Freedom from documented recurrence (off-AADs)
研究概览
简要总结
The goal of this clinical trial is to compare the rhythm control effect in hypertrophic non-obstructive patients with non-paroxysmal atrial fibrillation by either concomitant catheter endocardial and thoracoscopic epicardial ablation or catheter ablation alone. The study aims to see if concomitant hybrid ablation can more effectively achieve rhythm control effect than catheter ablation alone in non-paroxysmal atrial fibrillation patients with hypertrophic cardiomyopathy.
详细描述
After informed consent, 66 eligible admissions will be recruited in 2 centers. Eligible participants will be randomly divided (1:1) into either hybrid or catheter ablation arms, looking for a primary outcome of 1-year freedom from atrial arrhythmias.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients' age is ≥18 y
- •Clinically diagnosed hypertrophic cardiomyopathy (any left ventricular wall segment thickness ≥15 mm in genetical negative (or unknown genetical status) patients or ≥13mm in genetical positive ones-as measured by any imaging technique (echocardiography, cardiac magnetic resonance imaging or computed tomography)-that is not explained solely by loading conditions)
- •Non-obstructed left ventricular outflow obstruction with peak gradients <30mmHg
- •Concomitant with persistent atrial fibrillation (7 days<sustained episode lasting<3 years) with drug-refractory symptoms.
- •Be able to understand the contents of the trial, and provide written informed consent to participate in this investigation.
排除标准
- •Patients with left atrial size >60 mm (2-dimensional echocardiography, parasternal long-axis view)
- •Contraindicated to systemic anticoagulation
- •Left ventricular ejection fraction ≤40%
- •Concomitant with left atrium or left atrial appendage emboli
- •Concomitant with a coronary or valvular disease that indicates intervention
- •Ischaemic stroke within 2 months
- •Previous ablation history
- •Uncontrolled hyper/hypothyroidism
- •End-staged kidney failure
- •Concomitantly involved in other trials
- •Pregnant or breastfeeding, or women of childbearing age not using a reliable contraceptive method
- •Concomitant with bacteremia or at an active phase of infection
- •Anatomically not suitable for thoracoscopic surgery(history of chest surgery or radiotherapy, etc.)
- •Unwilling or unable to comply with all peri-ablation and follow-up requirements
结局指标
主要结局
Freedom from documented recurrence (off-AADs)
时间窗: within 3-12 months
freedom from documented AF/AT episodes \>30 seconds (off-AADs) by 72-hour holter monitoring
次要结局
- All cause mortality(within 12 months)
- Cardiovascular related mortality(within 12 months)
- Cerebral infarction/ischemia(within 12 months)
- Periferal arterial embolism(within 12 months)
- All-cause rehospitalization(within 3-12 months)
- Freedom from documented recurrence (on-AADs)(within 3-12 months)
- Heart failure related rehospitalization(within 3-12 months)