Cardiac Resynchronization in the Elderly: Piloting Pacemaker vs. Defibrillator Therapy (Randomized Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 102
- Locations
- 6
- Primary Endpoint
- Enrollment
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 75 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Arms & Interventions
Randomized- Defibrillator (CRT-D)
Cardiac resynchronization therapy Defibrillator
Intervention: 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
Intervention: Cardiac Resynchronization Therapy Pacemaker (Device)
Randomized- Pacemaker (CRT-P)
Cardiac resynchronization therapy Pacemaker
Intervention: 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
Intervention: Cardiac Resynchronization Therapy Defibrillator (Device)
Outcomes
Primary Outcomes
Enrollment
Time Frame: At 1 year after start of the study
Rates of enrollment of participants in this randomized trial
Secondary Outcomes
- 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)
Investigators
Samir Saba
Associate Professor; Associate Chief of Cardiology; Director of Cardiovascular Electrophysiology
University of Pittsburgh