At a glance
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Cardiac Resynchronization in the Elderly: Piloting Pacemaker vs. Defibrillator Therapy (Randomized Trial)
In Brief
A clinical study evaluating Cardiac Resynchronization Therapy Pacemaker and Cardiac Resynchronization Therapy Defibrillator for Heart Failure. Completed, enrolled 102 participants across 6 sites.
Detailed 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.
Study Details
Timeline
Interventions
Patients randomized to the pacemaker arm will receive a CRT-P device.
Patients randomized to the defibrillator arm will receive a CRT-D device.