Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation- the BUDAPEST CRT TAVI Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Primary outcome
研究概览
简要总结
In this prospective, randomized, multicenter, open-label interventional clinical trial, the investigators' aim to test the effect of Cardiac Resynchronization Therapy (CRT) in cases of new-onset and persistent Left Bundle Branch Block (LBBB) occurring in the context of Transcatheter Aortic Valve Implantation (TAVI), in patients with moderately reduced left ventricular systolic function (35% < EF < 55%). The investigators hypothesize that in patients with persistent LBBB developing after TAVI and mildly reduced left ventricular systolic function (35% < EF < 55%), early postoperative CRT implantation favorably influences the process of myocardial reverse remodeling by reducing electromechanical dyssynchrony, thereby decreasing the combined endpoint of heart failure-related hospitalizations and mortality at one year.
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
- None
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
- •Age over 18 years
- •Successful and complication-free TAVI implantation for significant aortic stenosis
- •Signed informed consent after detailed patient information
- •New-onset LBBB wider than 130 ms after TAVI, persisting at the time of planned discharge (assessed postoperatively on or after day 5)(21)
- •Mildly reduced left ventricular systolic function on echocardiography at the planned time of discharge (at the earliest on postoperative day 5), with EF between 35% and 55%
排除标准
- •Pre-existing right bundle branch block, or prior pacemaker/ICD implantation associated with significant (>20%) ventricular pacing
- •Progression of LBBB during hospitalization to a degree indicating pacemaker implantation (e.g., Mobitz II or third-degree AV block, alternating bundle branch block) before the planned discharge date
- •Concomitant severe valvular disease of other valves (mitral, pulmonary, or tricuspid)
- •Severe infection and/or septic state
- •TAVI-associated stroke
- •More than moderate paravalvular leak of the TAVI valve on postoperative echocardiography
- •EF < 35% or > 55% on echocardiography performed at the planned time of discharge
- •GOLD stage IV COPD
- •Chronic renal failure requiring regular dialysis
- •Concurrent participation in another clinical trial
研究组 & 干预措施
CRT
CRT implantation
干预措施: CRT implantation (Device)
Standard of Care
结局指标
主要结局
Primary outcome
时间窗: 12 months
Elapsed time to heart failure hospitalisation or all-cause mortality
次要结局
未报告次要终点