Cardiac Resynchronization in the Elderly

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.

Inclusion Criteria:

1. Age >/= 75 years

2. Left Ventricular Ejection Fraction (LVEF) ≤ 35% by cardiac imaging including
echocardiogram, nuclear imaging, cardiac catheterization, or cardiac magnetic
resonance imaging

3. QRS width >120 ms on surface electrocardiogram

4. New York Heart Association class II, III, or ambulatory IV for Heart Failure (HF)

5. Patient undergoing de novo CRT device implantation of CRT-D device change-out for
battery depletion

Exclusion Criteria:

1. Patient within 40 days of acute myocardial infarction

2. Patient within 3 months of cardiac revascularization (percutaneous coronary
intervention or bypass surgery)

3. Patient with prior history of cardiac arrest or documented sustained ventricular
arrhythmia

4. Patient with expected longevity < 1 year

5. Patient not on optimal medical therapy for HF management including when tolerated
β-blockers, angiotensin converting enzyme inhibitors or angiotensin receptor blockers

6. Patient not planning to have his/her follow-up at participating institution

7. Patient unable or unwilling to sign a written informed consent

8. Patient's with dementia that are unable to consent for themselves

9. Participating in any other clinical trials (observational/registries allowed)