His-Bundle Corrective Pacing in Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 14
- 主要终点
- Change in Left Ventricular Ejection Fraction at 6 months with His-CRT vs. BIV-CRT, in heart failure patients with Right bundle branch block (RBBB)
研究概览
简要总结
The investigators aim to prospectively evaluate the efficacy and mechanism of benefit of His-bundle pacing enhanced cardiac resynchronization therapy (His-CRT) vs. cardiac resynchronization therapy (BIV-CRT) in patients with heart failure and right bundle branch block (RBBB).
详细描述
In this prospective, randomized, multi-center clinical trial, the investigators aim to prospectively evaluate the efficacy and mechanism of benefit of His-bundle pacing enhanced cardiac resynchronization therapy (His-CRT) vs. cardiac resynchronization therapy (BIV-CRT) in patients with Right Bundle Branch Block (RBBB) Electrocardiogram (ECG) Pattern by assessing the improvement in left ventricular ejection fraction (LVEF) in the His-CRT vs. BIV-CRT arm at 6 months, and by evaluating changes in ECG biomarkers, NT-pro-brain natriuretic peptide (NT-proBNP) levels, and echocardiography biomarkers (left ventricular volumes, strain contractility, and dyssynchrony), as well as temporal changes in functional status and quality of life in the His-CRT vs. BIV-CRT arm at 6, 12, and 24 months.
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
- •Age 18 years or older (no upper age limit)
- •Optimal medical therapy for heart failure by current guidelines
- •Class IIa or IIb guideline-based indication for CRT-D implant in RBBB patients, including one of the following:
- •New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb); OR
- •NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa); OR
- •NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration 120-149 ms (IIb)
排除标准
- •Unable to obtain most recent imaging data from echocardiogram within 1 year prior to date of randomization
- •Left bundle branch block (LBBB) or intraventricular conduction delay (IVCD) ECG morphology
- •Unable or unwilling to follow study protocol
- •Less than 12 months life expectancy at consent
- •Pregnancy or planned pregnancy during duration of the study
- •On heart transplant list or likely to undergo heart transplant
研究组 & 干预措施
His-CRT implantation
His-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an endocardial His-bundle pacing leads directly pacing the intrinsic conduction system.
干预措施: His-CRT implantation (Procedure)
BIV-CRT implantation
BIV-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an epicardial left ventricular lead implanted in a branch of the coronary sinus.
干预措施: BIV-CRT implantation (Procedure)
结局指标
主要结局
Change in Left Ventricular Ejection Fraction at 6 months with His-CRT vs. BIV-CRT, in heart failure patients with Right bundle branch block (RBBB)
时间窗: 6 month
The effect of His-CRT vs. BIV-CRT on left ventricular ejection fraction (as a percentage) measured during an echocardiography imaging study will be analyzed using an analysis of covariance model for changes in LVEF from pre-implantation (baseline) to post-implantation (6 months follow-up), with randomized treatment group as the factor of interest, and baseline LVEF as a covariate. A t-test will be performed using this model to compare the adjusted group means, and a confidence interval will be constructed for their difference.
次要结局
- Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-systolic volume (LVESV)(6 months)
- Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-diastolic volume (LVEDV)(6 months)
- Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in ECG biomarkers(6 months)
- Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in NT-proBNP(6 months)
研究者
Valentina Kutyifa
Associate Professor of Medicine
University of Rochester