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Cardiac Resynchronization in the Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031847
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Samir Saba, University of Pittsburgh

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, open-label, controlled trial of CRT-P vs. CRT-D in octogenarians
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
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Pacemaker
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

Defibrillator
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




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. Heath Care Cost [ Time Frame: at 6 months after enrollment ]
    Cost of health care between CRT-P and CRT-D recipients

  2. 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

  3. QOL2 [ Time Frame: At 6 months after enrollment ]
    QOL of CRT-P versus CRT-D recipients using RAND-36

  4. Retention [ Time Frame: At 6 months after enrollment ]
    Rates of retention of participants in this randomized trial



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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031847


Contacts
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Contact: Samir Saba, MD 412-647-2762 sabas@upmc.edu

Locations
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United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Contact: Sana Al-Khatib         
Principal Investigator: Sana Al-Khatib, MD         
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Raul Weiss, MD         
Principal Investigator: Raul Weiss, MD         
United States, Pennsylvania
UPMC Hamot Recruiting
Erie, Pennsylvania, United States, 16550
Contact: Madhurmeet Singh         
Principal Investigator: Madhurmeet Singh         
UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Samir Saba         
Principal Investigator: Samir Saba, MD         
Veterans Research Foundation of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Alaa Shalaby, MD         
Principal Investigator: Alaa Shalaby         
UPMC Pinnacle Recruiting
Wormleysburg, Pennsylvania, United States, 17043
Contact: Michael Link, MD         
Principal Investigator: Michael Link         
Sponsors and Collaborators
Samir Saba
Investigators
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Principal Investigator: Samir Saba, MD University of Pittsburgh
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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    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases