Cardiac Resynchronization in the Elderly

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

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 Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Cardiac Resynchronization Therapy Pacemaker; Device: Cardiac Resynchronization Therapy Defibrillator

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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16550
      • UPMC Hamot
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC
    • Pittsburgh, Pennsylvania, United States, 15240
      • Veterans Research Foundation of Pittsburgh
    • Wormleysburg, Pennsylvania, United States, 17043
      • UPMC Pinnacle

Participation Criteria

Eligibility Criteria

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

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: CRT-P
Other: 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 Names: CRT-D
Other: 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 Names: CRT-P
Other: 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 Names: CRT-D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment	Rates of enrollment of participants in this randomized trial	At 1 year after start of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QOL	Quality of life of CRT-P versus CRT-D recipients using Minnesota Living with Heart Failure Questionnaires. The Minnesota Living with Heart Failure scale ranges from 0 to 105, in which a lower score indicates a better outcome. The Minnesota Living with Heart Failure Physical subscale ranges from 0 to 40 and the Minnesota Living with Heart Failure Mental subscale ranges from 0 to 25. Lower scores on the subscales indicate a better outcome.	At 6 months after enrollment
QOL2	QOL of CRT-P versus CRT-D recipients using RAND-36. The RAND-36 is a normalized scale with a range of 0 to 100, in which a higher score is indicative of a better outcome. PCS-T and MCS-T are the two summary components of the RAND-36. The subscales PCS-T and MCS-T are both normalized with a range of 0 to 100. Higher scores on the subscales indicate a better outcome.	At 6 months after enrollment
Retention	Rates of retention of participants in this randomized trial	At 6 months after enrollment
Health Care Cost	Cost of health care between CRT-P and CRT-D recipients.	At 6 months after enrollment

Collaborators and Investigators

• Sponsor: Samir Saba
• Investigators: Principal Investigator: Samir Saba, MD, University of Pittsburgh

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2017
• Primary Completion (Actual): August 18, 2021
• Study Completion (Actual): August 18, 2021

Study Registration Dates

• First Submitted: January 19, 2017
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimated): January 26, 2017

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: PRO17010015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes