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Cardiac Resynchronization in the Elderly

NCT03031847 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2023-12-07

Study results available
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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.

Conditions

Interventions

DEVICE

Cardiac Resynchronization Therapy Pacemaker

Patients randomized to the pacemaker arm will receive a CRT-P device.

DEVICE

Cardiac Resynchronization Therapy Defibrillator

Patients randomized to the defibrillator arm will receive a CRT-D device.

Sponsors & Collaborators

  • Samir Saba

    lead OTHER

Principal Investigators

  • Samir Saba, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-21
Primary Completion
2021-08-18
Completion
2021-08-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03031847 on ClinicalTrials.gov