NCT05985408尚未招募不适用
Left Ventricular Septal Pacing Based Rescue CRT Versus Right Ventricular Apical Pacing Based CRT for Chronic Heart Failure: a Randomized Controlled Trial
Fu Wai Hospital, Beijing, China1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- left ventricular ejection fraction (LVEF)
研究概览
简要总结
To find out whether left ventricular septal pacing (LVSP)-based cardiac resynchronization therapy (CRT) is superior to right ventricular apical pacing (RVAP)-based CRT in patients with failed left bundle branch pacing at the beginning of chronic 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic heart failure, LVEF ≤35% after at least 3 months of guideline-optimized drug therapy, NYHA class II-IV with complete left bundle branch block (QRSd≥130 ms), OR Atrioventricular block with LVEF ≤ 50% with the indication of cardiac pacing;
- •Age between 18 and 90 years old;
- •The expected survival period is greater than 12 months;
- •Signed the informed consent form for the study.
排除标准
- •Previous mechanical tricuspid valve replacement.
- •Previous pacemaker or other devices implanted and for device replacement or upgrading for this time.
- •Patients have a history of unstable angina, acute myocardial infarction, CABG, and PCI surgery within three months.
- •Persistent atrial fibrillation without AV block, the proportion of biventricular pacing is not expected to less than 95%.
- •Patients participated in any of the other studies at the same time, which may confound the results of this study.
- •Pregnancy, planning to become pregnant.
- •Patients with a history of heart transplantation.
结局指标
主要结局
left ventricular ejection fraction (LVEF)
时间窗: 12 months
LVEF evaluated by echocardiography，Bi-plane Simpson's method
left ventricular end-systolic volume (LVESV)
时间窗: 12 months
LVESV evaluated by echocardiography
次要结局
- NT-proBNP(12 months)
- paced QRSd duration.(12 months)
- 6-minute hall walk distance(12 months)
- All cause death(12 months)
- Heart failure rehospitalization(12 months)
- Rehospitalization for cardiovascular adverse events(12 months)
- Malignant ventricular arrhythmias(12 months)
研究者
Li Xiaofei
Doctor
Fu Wai Hospital, Beijing, China
研究点 (1)
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