Cardiac Resynchronization in the Elderly

ClinicalTrials.gov ID: NCT03031847

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Official title

Cardiac Resynchronization in the Elderly: Piloting Pacemaker vs. Defibrillator Therapy (Randomized Trial)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT03031847
Recruitment status: Completed
Study type: Interventional
Phase: Not applicable
Lead sponsor: Samir Saba; Other
Enrollment: 102 participants

Conditions and interventions

Conditions

Heart Failure

Interventions

Device

Eligibility (public fields only)

Age range: 75 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 21, 2017 (Actual)
Primary completion: Aug 18, 2021 (Actual)
Completion: Aug 18, 2021 (Actual)
Last update posted: Dec 7, 2023

2017 – 2021

United States locations

U.S. sites: 6
U.S. states: 3
U.S. cities: 5

Facility	City	State	ZIP	Site status
Duke University Health System	Durham	North Carolina	27710	—
The Ohio State University	Columbus	Ohio	43210	—
UPMC Hamot	Erie	Pennsylvania	16550	—
UPMC	Pittsburgh	Pennsylvania	15213	—
Veterans Research Foundation of Pittsburgh	Pittsburgh	Pennsylvania	15240	—
UPMC Pinnacle	Wormleysburg	Pennsylvania	17043	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03031847, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 7, 2023 · Synced Nov 15, 2026