Cardiac Resynchronization in the Elderly

NCT03031847 | Completed Results DMC FDA Device

• 1 other identifier: PRO17010015
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 6

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Enrollment

  Rates of enrollment of participants in this randomized trial

  At 1 year after start of the study

Secondary Outcomes (4)

• QOL

  At 6 months after enrollment

• QOL2

  At 6 months after enrollment

• Retention

  At 6 months after enrollment

• Health Care Cost

  At 6 months after enrollment

Study Arms (4)

Randomized- Pacemaker (CRT-P)

OTHER

Cardiac resynchronization therapy Pacemaker

Device: Cardiac Resynchronization Therapy Pacemaker

Randomized- Defibrillator (CRT-D)

OTHER

Cardiac resynchronization therapy Defibrillator

Device: Cardiac Resynchronization Therapy Defibrillator

Observational- Pacemaker (CRT-P)

OTHER

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

Observational- Defibrillator (CRT-D)

OTHER

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

Interventions

Cardiac Resynchronization Therapy Pacemaker DEVICE

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

Also known as: CRT-P

Observational- Pacemaker (CRT-P); Randomized- Pacemaker (CRT-P)

Cardiac Resynchronization Therapy Defibrillator DEVICE

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

Also known as: CRT-D

Observational- Defibrillator (CRT-D); Randomized- Defibrillator (CRT-D)

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \>/= 75 years
• Left Ventricular Ejection Fraction (LVEF) ≤ 35% by cardiac imaging including echocardiogram, nuclear imaging, cardiac catheterization, or cardiac magnetic resonance imaging
• QRS width \>120 ms on surface electrocardiogram
• New York Heart Association class II, III, or ambulatory IV for Heart Failure (HF)
• Patient undergoing de novo CRT device implantation of CRT-D device change-out for battery depletion

You may not qualify if:

• Patient within 40 days of acute myocardial infarction
• Patient within 3 months of cardiac revascularization (percutaneous coronary intervention or bypass surgery)
• Patient with prior history of cardiac arrest or documented sustained ventricular arrhythmia
• Patient with expected longevity \< 1 year
• Patient not on optimal medical therapy for HF management including when tolerated β-blockers, angiotensin converting enzyme inhibitors or angiotensin receptor blockers
• Patient not planning to have his/her follow-up at participating institution
• Patient unable or unwilling to sign a written informed consent
• Patient's with dementia that are unable to consent for themselves
• Participating in any other clinical trials (observational/registries allowed)

Sponsors & Collaborators

• Samir Saba: lead

Study Sites (6)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

UPMC Hamot

Erie, Pennsylvania, 16550, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Veterans Research Foundation of Pittsburgh

Pittsburgh, Pennsylvania, 15240, United States

Location

UPMC Pinnacle

Wormleysburg, Pennsylvania, 17043, United States

Location

Related Publications (2)

• 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.

  PMID: 36350362 DERIVED

• 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.

  PMID: 35357219 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Eric Pasquantonio
• Organization: UPMC Presbyterian Hospital

pasquantonioej@upmc.edu

4126478210

Study Officials

• Samir Saba, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor; Associate Chief of Cardiology; Director of Cardiovascular Electrophysiology

Model Details: Randomized, open-label, controlled trial of CRT-P vs. CRT-D in HF patients (age ≥ 75 years)

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 26, 2017
• Study Start: March 21, 2017
• Primary Completion: August 18, 2021
• Study Completion: August 18, 2021
• Last Updated: December 7, 2023
• Results First Posted: August 23, 2022

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)