Cardiac Resynchronization in the Elderly: Piloting Pacemaker vs. Defibrillator Therapy (Randomized Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 6
- 主要终点
- Enrollment
研究概览
简要总结
This pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State University, and the VA Pittsburgh Healthcare System. Patients will be randomized to CRT-P versus CRT-D and followed until study end. Rates of patient screening, enrollment, randomization, and retention as well as cost of care will be examined. The results of this pilot study will inform the design of a large pivotal non-inferiority trial and will be necessary for its success. Patients who refuse participation in the randomized pilot trial will be asked to enroll in a prospective observational cohort. Characteristics of patients who choose CRT-P vs. CRT-D will be compared and patients' level of satisfaction with their device decision will be measured.
详细描述
The goal of this study is to pilot test a randomized, controlled, non-inferiority trial comparing the survival and quality of life (QOL) of older patients receiving cardiac resynchronization therapy (CRT) pacemaker (CRT-P) versus defibrillator (CRT-D) therapy. This pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State University, and the VA Pittsburgh Healthcare System. Patients will be randomized to CRT-P versus CRT-D and followed until study end. Rates of patient screening, enrollment, randomization, and retention as well as cost of care will be examined. The results of this pilot study will inform the design of a large pivotal non-inferiority trial and will be necessary for its success. Patients who refuse participation in the randomized pilot trial will be enrolled and followed as part of a prospective observational cohort. Characteristics of patients who choose CRT-P vs. CRT-D will be compared and patients' level of satisfaction with their device decision will be measured.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >/= 75 years
- •Left Ventricular Ejection Fraction (LVEF) ≤ 35% by cardiac imaging including echocardiogram, nuclear imaging, cardiac catheterization, or cardiac magnetic resonance imaging
- •QRS width >120 ms on surface electrocardiogram
- •New York Heart Association class II, III, or ambulatory IV for Heart Failure (HF)
- •Patient undergoing de novo CRT device implantation of CRT-D device change-out for battery depletion
排除标准
- •Patient within 40 days of acute myocardial infarction
- •Patient within 3 months of cardiac revascularization (percutaneous coronary intervention or bypass surgery)
- •Patient with prior history of cardiac arrest or documented sustained ventricular arrhythmia
- •Patient with expected longevity < 1 year
- •Patient not on optimal medical therapy for HF management including when tolerated β-blockers, angiotensin converting enzyme inhibitors or angiotensin receptor blockers
- •Patient not planning to have his/her follow-up at participating institution
- •Patient unable or unwilling to sign a written informed consent
- •Patient's with dementia that are unable to consent for themselves
- •Participating in any other clinical trials (observational/registries allowed)
研究组 & 干预措施
Randomized- Defibrillator (CRT-D)
Cardiac resynchronization therapy Defibrillator
干预措施: Cardiac Resynchronization Therapy Defibrillator (Device)
Observational- Pacemaker (CRT-P)
Cardiac resynchronization therapy Pacemaker (CRT-P): Patients in this arm declined randomization in the trial and elected to participate in the observational registry
干预措施: Cardiac Resynchronization Therapy Pacemaker (Device)
Randomized- Pacemaker (CRT-P)
Cardiac resynchronization therapy Pacemaker
干预措施: Cardiac Resynchronization Therapy Pacemaker (Device)
Observational- Defibrillator (CRT-D)
Cardiac resynchronization therapy Defibrillator (CRT-D): Patients in this arm declined randomization in the trial and elected to participate in the observational registry
干预措施: Cardiac Resynchronization Therapy Defibrillator (Device)
结局指标
主要结局
Enrollment
时间窗: At 1 year after start of the study
Rates of enrollment of participants in this randomized trial
次要结局
- Health Care Cost(At 6 months after enrollment)
- QOL(At 6 months after enrollment)
- QOL2(At 6 months after enrollment)
- Retention(At 6 months after enrollment)
研究者
Samir Saba
Associate Professor; Associate Chief of Cardiology; Director of Cardiovascular Electrophysiology
University of Pittsburgh