Pacing of the Left Bundle Branch Area NEcessitated After TAVR
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- QRS duration
研究概览
简要总结
Prospective, randomized, single center clinical trial to compare the outcome of left bundle branch area pacing versus right ventricular apical pacing in patients with higher degree atrio-ventricular block and a normal left ventricular function after transcatheter aortic valve replacement.
详细描述
Transcatheter aortic valve replacement (TAVR) is a well-established treatment of aortic valve stenosis. Yet, requiry of permanent pacing due to new onset atrio-ventricular conduction block remains a frequent complication. Standard right ventricular pacing (RVP) at high pacing burden may lead to deterioration of left ventricular function. Left-Bundle-Area Pacing (LBBP) is a new, innovative method of physiological ventricular stimulation resulting in narrow, physiological QRS complexes.
In this prospective, randomized, single center clinica trial, patients are included after TAVR and with normal left ventricular function who require pacing due to a higher degree atriao-ventricular block with an anticipated high pacing burden. Patients will be randomized to receive either left bundle branch area pacing (intervention) or right ventricular apical pacing (control).
The results will confirm the feasibility of LBBP in patients following TAVR. Results will further investigate the primary outcome of a clinically relevant QRS narrowing and a combination of exploratory secondary endpoints including clinical outcomes, functional status, laboratory biomarkers, and quality of life.
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
- •Successful TAVR implantation for classical (high flow high gradient), symptomatic aortic valve stenosis
- •LVEF ≥50%
- •Guideline-based indication for pacing due to AV block III°, AV block II°, or symptomatic bradycardic atrial fibrillation with an expecteed ventricular pacing burden >20%
- •Signed informeed conseent to study participation
排除标准
- •LVEF <50%
- •Expected pacing burden <20%
- •Pre-existing implanted cardiac device
- •Participation in a concurring interventional trial
- •age <18 years
- •Current preegnancy
- •life expectancy <6 months
结局指标
主要结局
QRS duration
时间窗: 3 months
QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads
次要结局
- Death of any cause(24 months)
- Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency(24 months)
- QRS duration(24 months)
- Death of cardio-vascular cause(24 months)
- Re-hospitalization due to heart failure(24 months)
- Change in left ventricular ejection fraction(24 months)
- Change in echocardiographic left ventricular enddiastolic diameter(24 months)
- Echocardiographic assessment of right ventricular ejection fraction(24 months)
- Change in New York heart failure classification status(24 months)
- Change in laboratory biomarkers NT-proBNP(24 months)
- Change in functional status by 6 minute walk(24 months)
- Change in EQ-5D quality of life(24 months)
- Occurence of arrhythmias(24 months)
研究者
Moritz F. Sinner
Assistant Professor
Ludwig-Maximilians - University of Munich