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Cardiac Resynchronization in the Elderly

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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

Tracking Information
First Submitted Date  ICMJE January 19, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date February 17, 2020
Actual Study Start Date  ICMJE March 21, 2017
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Enrollment [ Time Frame: At 1 year after start of the study ]
Rates of enrollment of participants in this randomized trial
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • Heath Care Cost [ Time Frame: at 6 months after enrollment ]
    Cost of health care between CRT-P and CRT-D recipients
  • 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
  • QOL2 [ Time Frame: At 6 months after enrollment ]
    QOL of CRT-P versus CRT-D recipients using RAND-36
  • Retention [ Time Frame: At 6 months after enrollment ]
    Rates of retention of participants in this randomized trial
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiac Resynchronization in the Elderly
Official Title  ICMJE Cardiac Resynchronization in the Elderly: Piloting Pacemaker vs. Defibrillator Therapy (Randomized Trial)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Device: Cardiac Resynchronization Therapy Pacemaker
    Patients randomized to the pacemaker arm will receive a CRT-P device.
    Other Name: CRT-P
  • Device: Cardiac Resynchronization Therapy Defibrillator
    Patients randomized to the defibrillator arm will receive a CRT-D device.
    Other Name: CRT-D
Study Arms  ICMJE
  • Pacemaker
    Cardiac resynchronization therapy Pacemaker
    Intervention: Device: Cardiac Resynchronization Therapy Pacemaker
  • Defibrillator
    Cardiac resynchronization therapy Defibrillator
    Intervention: Device: Cardiac Resynchronization Therapy Defibrillator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 75 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Samir Saba, MD 412-647-2762 sabas@upmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03031847
Other Study ID Numbers  ICMJE PRO17010015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Samir Saba, University of Pittsburgh
Study Sponsor  ICMJE Samir Saba
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Samir Saba, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP