NCT05541679进行中（未招募）不适用
Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Disease After Transcatheter Aortic Valve Replacement
Main Line Health8 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年12月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
- 试验地点
- 8
- 主要终点
- Change in left ventricular ejection fraction (LVEF%)
研究概览
简要总结
The purpose of the study is to investigate the superiority of chronic left bundle branch area pacing compared to traditional right ventricular (RV) septal pacing in patients with high-grade conduction disease after transcatheter aortic valve replacement (TAVR). In this investigator initiated, multicenter, prospective, double-blinded, crossover study, chronic left bundle branch area pacing will be compared to chronic right ventricular septal pacing using echocardiographic measures of left ventricular systolic function in patients with a high cumulative ventricular pacing burden after TAVR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Subject has at least one of these conduction disturbances:
- •Symptomatic (or hemodynamically significant) bradycardia or symptomatic persistent atrioventricular block including first-degree and Mobitz I (Wenckebach) or Mobitz type II atrioventricular bock
- •High-grade atrioventricular block
- •Third-degree atrioventricular block
- •Subject has undergone TAVR (any valve system) in the last four weeks
- •Subject is receiving a first-time pacemaker implant
- •Subject's most recent documented ejection fraction (by any method) within the past 90 days prior to study enrollment is > 50% (≥45% if visually estimated at the time of enrollment)
- •Subject is a male or female at least 18 years old at the time of consent
- •Subject is able to receive a left sided pectoral implant
排除标准
- •Subject has ever had a previous or has an existing implantable pulse generator (IPG), implantable cardiac defibrillator (ICD) or biventricular (BiV) implant
- •Subject has more than mild para-valvular regurgitation following TAVR implantation.
- •Subject has LVEF < 45% if visually estimated at the time of enrollment
- •Subject is indicated for a biventricular pacing device (CRT-P or CRT-D).
- •Subject is enrolled in a concurrent study that may confound the results of this study
- •Subject has a mechanical heart valve
- •Subject is pregnant, or of childbearing potential and not on a reliable form of birth control
- •Subject status post heart transplant
- •Subject life expectancy less than 2 years
结局指标
主要结局
Change in left ventricular ejection fraction (LVEF%)
时间窗: 9 months
Primary efficacy outcome
Change in global longitudinal strain (GLS%)
时间窗: 9 months
Primary efficacy outcome
Composite of left bundle branch area pacing lead septal myocardial or coronary artery perforation, lead dislodgment, and repeat procedures related to left bundle branch area lead implantation
时间窗: 18 months
Primary safety endpoint
次要结局
- Left bundle branch area pacing lead impedence(18 months)
- Adverse events related to device function(18 months)
- Quality of life measured using the Minnesota Living with Heart Failure questionnaire (MLHQ)(9 months)
- Right ventricular global longitudinal strain (RVGLS%)(9 months)
- Mortality(18 months)
- Severity of mitral regurgitation(18 months)
- Left bundle branch area pacing lead pacing threshold(18 months)
- Brain natriuretic peptide or N-terminal pro-brain natriuretic peptide concentration(9 months)
- Functional capacity measured using the New York Heart Association functional classification (NYHA)(9 months)
- Hospitalizations for heart failure(18 months)
- Left ventricular mechanical systolic dyssynchrony indexed to heart rate (SDI)(9 months)
- Severity of tricuspid regurgitation(18 months)
- Left bundle branch area pacing lead sensed R wave amplitude(18 months)
- Left ventricular end-systolic volume(9 months)
- Six minute walk test score(9 months)
- Interventricular mechanical delay (IVMD)(9 months)
- Left ventricular stroke volume(9 months)
研究者
研究点 (8)
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