Cardiac Resynchronization Therapy Using His/Left Bundle Branch Pacing vs Biventricular Pacing With a Left Ventricular Epicardial Lead in Patients With Heart Failure (HF) With Left Ventricular Ejection Fraction (LVEF)≤50% and With Either a Wide QRS Complex (>130 ms) or With/Anticipated >40% Pacing Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,136
- 试验地点
- 136
- 主要终点
- A combined clinical endpoint of all-cause mortality and hospitalization for heart failure
研究概览
简要总结
The investigators aim to prospectively test the comparative effectiveness of His or Left bundle branch pacing in relation to patient centered outcomes (quality of life, physical activity, heart failure hospitalization, mortality) and comparative safety in relation to device-related complications and re-interventions (e.g., lead dislodgement, infection) relative to standard of care biventricular pacing in patients with heart failure due to left ventricular systolic dysfunction (LVEF≤50%) and with either a wide QRS (≥130 ms) or with/anticipated >40% pacing who are already receiving current standard heart failure pharmacological therapy.
详细描述
In this prospective, randomized, multi-center clinical trial, the investigators aim to prospectively evaluate the comparative effectiveness His or Left bundle branch pacing (His/LBBP) vs. biventricular pacing (BiVP) in patients with heart failure due to left ventricular systolic dysfunction (LVEF≤50%) and with either a wide QRS (≥130 ms) or with/anticipated >40% pacing who are already receiving current standard heart failure pharmacological therapy by assessing all cause death and heart failure hospitalization at the end of the study.
Additional formal secondary objectives include evaluation disease-specific quality and psychological adjustment changes at 1 year after device implant and evaluation of a composite of death of any cause or heart failure hospitalization or more >15% increase in the left ventricular end-systolic volume index at the end of the study.
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
- Triple (Participant, Care Provider, 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
- •Men and women 18 years of age or older.
- •A LVEF ≤ 50% within 6 months prior to enrollment.
- •Resting QRS duration ≥130 ms as evidenced by a historical 12-lead ECG prior to enrollment OR anticipated right ventricular pacing >40% OR device in place with right ventricular pacing > 40%.
- •Are optimized on HF guideline directed medical therapy according to current HF published guidelines OR patient's physician will make an effort to start all guideline-directed medical therapy and titrate doses up as permitted by the participant clinical status and co-morbidities prior to implantation procedure.
排除标准
- •Women who are pregnant, lactating, or plan to become pregnant during the course of the trial.
- •Participants with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary, intervention in the next three (3) months.
- •Enzyme-positive myocardial infarction within the past three (3) months prior to enrollment.
- •Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past three (3) months prior to enrollment.
- •Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis).
- •Participants with Chagas disease, cardiac sarcoidosis or amyloidosis.
- •Expected to receive left ventricular assist device or heart transplantation within 6 months.
- •Participants with primary severe valvular disease (e.g., aortic stenosis).
- •Have a life expectancy of less than 12 months.
- •Participants with irreversible brain damage from preexisting cerebral disease.
- •Participants with a contrast dye allergy unable or unwilling to undergo pretreatment with steroids and/or diphenhydramine.
- •Participants participating in any other interventional cardiovascular clinical trial.
- •Participants who would be unable to comply with the study's follow-up visit schedule; or
- •Participants who had any prior unsuccessful attempt at implantation of biventricular pacing (BiVP), His Bundle Pacing (HBP), or Left Bundle Branch Pacing (LBBP) device.
结局指标
主要结局
A combined clinical endpoint of all-cause mortality and hospitalization for heart failure
时间窗: 5.5 years
The primary efficacy outcome will be described using Kaplan-Meier freedom from event curves over time, with event-free survival compared between assigned treatment arms using a logrank test, stratified by levels of the two factors (LVEF (≤35% vs. 36 to 50%) and conduction abnormality (LBBB vs non-LBBB)) used for randomization.
次要结局
- Assess change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) at 12 months(12 months)
- Change in composite endpoint comprised of death, first hospitalization for worsening HF and left ventricular end systolic volume index (LVESVi) at 5.5 years(5.5 years)
- Composite of cardiovascular death or heart transplant or durable left ventricular assist device or more > 15% increase in the LVESVi or change in KCCQ-12 at the end of the study using win ratio(5.5 years)
- Death from any cause at 5.5 years(5.5 years)
- Death from any cardiovascular cause at 5.5 years(5.5 years)
- Hospitalization for heart failure at 5.5 years(5.5 years)
- Cardiovascular hospitalization at 5.5 years(5.5 years)
- Total HF hospitalizations(5.5 years)
- Composite of cardiovascular death or first HF hospitalization(5.5 years)
- Composite cardiovascular death or HF hospitalization or heart transplant or durable left ventricular assist device(5.5 years)
- Change in NYHA Classification at 12 months(12 months)
- Change in Six Minute Walk Test performance at 12 months(12 months)
- Patient activity measured through cardiovascular implantable electronic devices (CIED) at 12 months(12 months)
- Change in NT-proBNP at 12 months(12 months)
研究者
Mihail Gabriel Chelu
Associate Professor
Baylor College of Medicine