Cardiac Resynchronization in the Elderly

• ClinicalTrials.gov Identifier: NCT03031847
• Recruitment Status: Completed
• First Posted: January 26, 2017
• Last Update Posted: June 16, 2022
• Sponsor: Samir Saba
• Information provided by (Responsible Party): Samir Saba, University of Pittsburgh

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Heart Failure	Device: Cardiac Resynchronization Therapy Pacemaker; Device: Cardiac Resynchronization Therapy Defibrillator	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, open-label, controlled trial of CRT-P vs. CRT-D in HF patients (age ≥ 75 years)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cardiac Resynchronization in the Elderly: Piloting Pacemaker vs. Defibrillator Therapy (Randomized Trial)
• Actual Study Start Date: March 21, 2017
• Actual Primary Completion Date: August 18, 2021
• Actual Study Completion Date: August 18, 2021

Arms and Interventions

Arm	Intervention/treatment
Randomized- Pacemaker (CRT-P); Cardiac resynchronization therapy Pacemaker	Device: Cardiac Resynchronization Therapy Pacemaker; Patients randomized to the pacemaker arm will receive a CRT-P device.; Other Name: CRT-P
Randomized- Defibrillator (CRT-D); Cardiac resynchronization therapy Defibrillator	Device: Cardiac Resynchronization Therapy Defibrillator; Patients randomized to the defibrillator arm will receive a CRT-D device.; Other Name: CRT-D
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	Device: Cardiac Resynchronization Therapy Pacemaker; Patients randomized to the pacemaker arm will receive a CRT-P device.; Other Name: CRT-P
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	Device: Cardiac Resynchronization Therapy Defibrillator; Patients randomized to the defibrillator arm will receive a CRT-D device.; Other Name: CRT-D

Outcome Measures

Primary Outcome Measures :

1. Enrollment [ Time Frame: At 1 year after start of the study ]
   Rates of enrollment of participants in this randomized trial

Secondary Outcome Measures :

1. QOL [ Time Frame: At 6 months after enrollment ]
   Quality of life of CRT-P versus CRT-D recipients using Minnesota Living with Heart Failure Questionnaires
2. QOL2 [ Time Frame: At 6 months after enrollment ]
   QOL of CRT-P versus CRT-D recipients using RAND-36
3. Retention [ Time Frame: At 6 months after enrollment ]
   Rates of retention of participants in this randomized trial

Eligibility Criteria

• Ages Eligible for Study: 75 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

United States, North Carolina

Duke University Health System

Durham, North Carolina, United States, 27710

United States, Ohio

The Ohio State University

Columbus, Ohio, United States, 43210

United States, Pennsylvania

UPMC Hamot

Erie, Pennsylvania, United States, 16550

UPMC

Pittsburgh, Pennsylvania, United States, 15213

Veterans Research Foundation of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15240

UPMC Pinnacle

Wormleysburg, Pennsylvania, United States, 17043

Sponsors and Collaborators

Samir Saba

Investigators

• Principal Investigator: Samir Saba, MD; University of Pittsburgh

More Information

• Responsible Party: Samir Saba, Associate Professor <Me; Associate Chief of Cardiology; Director of Cardiovascular Electrophysiology;, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03031847
• Other Study ID Numbers: PRO17010015
• First Posted: January 26, 2017
• Last Update Posted: June 16, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases