Cardiac Resynchronization in the Elderly

NCT ID: NCT03031847

Last Updated: 2023-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-21
• Study Completion Date: 2021-08-18

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Randomized- Pacemaker (CRT-P)

Cardiac resynchronization therapy Pacemaker

Group Type: OTHER

Cardiac Resynchronization Therapy Pacemaker

Intervention Type: DEVICE

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

Randomized- Defibrillator (CRT-D)

Cardiac resynchronization therapy Defibrillator

Group Type: OTHER

Cardiac Resynchronization Therapy Defibrillator

Intervention Type: DEVICE

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

Group Type: OTHER

Cardiac Resynchronization Therapy Pacemaker

Intervention Type: DEVICE

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

Group Type: OTHER

Cardiac Resynchronization Therapy Defibrillator

Intervention Type: DEVICE

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

Interventions

Cardiac Resynchronization Therapy Pacemaker

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

Intervention Type: DEVICE

Cardiac Resynchronization Therapy Defibrillator

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

Intervention Type: DEVICE

Other Intervention Names

CRT-P; CRT-D

Eligibility Criteria

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)

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samir Saba

OTHER

Sponsor Role: lead

Responsible Party

Samir Saba

Associate Professor; Associate Chief of Cardiology; Director of Cardiovascular Electrophysiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Samir Saba, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Duke University Health System

Durham, North Carolina, United States

The Ohio State University

Columbus, Ohio, United States

UPMC Hamot

Erie, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, United States

Veterans Research Foundation of Pittsburgh

Pittsburgh, Pennsylvania, United States

UPMC Pinnacle

Wormleysburg, Pennsylvania, United States

Countries

United States

References

Dhande M, Myaskovsky L, Althouse A, Singh M, Weiss R, Shalaby A, Al-Khatib SM, Topoll A, Jain S, Saba S. Quality of Life and Type of Cardiac Resynchronization Therapy Device in Older Heart Failure Patients. J Palliat Med. 2023 Apr;26(4):481-488. doi: 10.1089/jpm.2022.0217. Epub 2022 Nov 8.

Reference Type: DERIVED

PMID: 36350362 (View on PubMed)

Althouse AD, Jain SK, Shalaby A, Singh M, Weiss R, Myaskovsky L, Al-Khatib SM, Saba S. Feasibility of a Randomized Clinical Trial of Cardiac Resynchronization Therapy With or Without an Implantable Defibrillator in Older Patients. Circ Arrhythm Electrophysiol. 2022 Apr;15(4):e010795. doi: 10.1161/CIRCEP.121.010795. Epub 2022 Mar 31. No abstract available.

Reference Type: DERIVED

PMID: 35357219 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PRO17010015

Identifier Type: -

Identifier Source: org_study_id