Left vs Left Randomized Clinical Trial

Last updated: February 12, 2025
Sponsor: Baylor College of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Chest Pain

Heart Failure

Treatment

His/LBBP

BiVP

Clinical Study ID

NCT05650658
PLACER 2021C3- 24160
  • Ages > 18
  • All Genders

Study Summary

The investigators aim to prospectively test the comparative effectiveness of His or Left bundle branch pacing in relation to patient centered outcomes (quality of life, physical activity, heart failure hospitalization, mortality) and comparative safety in relation to device-related complications and re-interventions (e.g., lead dislodgement, infection) relative to standard of care biventricular pacing in patients with heart failure due to left ventricular systolic dysfunction (LVEF≤50%) and with either a wide QRS (≥130 ms) or with/anticipated >40% pacing who are already receiving current standard heart failure pharmacological therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women 18 years of age or older.

  • A LVEF ≤ 50% within 6 months prior to enrollment.

  • Resting QRS duration ≥130 ms as evidenced by a historical 12-lead ECG prior toenrollment OR anticipated right ventricular pacing >40% OR device in place withright ventricular pacing > 40%.

  • Are optimized on HF guideline directed medical therapy according to current HFpublished guidelines OR patient's physician will make an effort to start allguideline-directed medical therapy and titrate doses up as permitted by theparticipant clinical status and co-morbidities prior to implantation procedure.

Exclusion

Exclusion Criteria:

  • Women who are pregnant, lactating, or plan to become pregnant during the course ofthe trial.

  • Participants with angiographic evidence of coronary disease who are candidates forcoronary revascularization and are likely to undergo coronary artery bypass graftsurgery or percutaneous coronary, intervention in the next three (3) months.

  • Enzyme-positive myocardial infarction within the past three (3) months prior toenrollment.

  • Coronary artery bypass graft surgery or percutaneous coronary intervention (balloonand/or stent angioplasty) within the past three (3) months prior to enrollment.

  • Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis).

  • Participants with Chagas disease, cardiac sarcoidosis or amyloidosis.

  • Expected to receive left ventricular assist device or heart transplantation within 6months.

  • Participants with primary severe valvular disease (e.g., aortic stenosis).

  • Have a life expectancy of less than 12 months.

  • Participants with irreversible brain damage from preexisting cerebral disease.

  • Participants with a contrast dye allergy unable or unwilling to undergo pretreatmentwith steroids and/or diphenhydramine.

  • Participants participating in any other interventional cardiovascular clinicaltrial.

  • Participants who would be unable to comply with the study's follow-up visitschedule; or

  • Participants who had any prior unsuccessful attempt at implantation of biventricularpacing (BiVP), His Bundle Pacing (HBP), or Left Bundle Branch Pacing (LBBP) device.

Study Design

Total Participants: 2136
Treatment Group(s): 2
Primary Treatment: His/LBBP
Phase:
Study Start date:
September 13, 2023
Estimated Completion Date:
June 30, 2029

Study Description

In this prospective, randomized, multi-center clinical trial, the investigators aim to prospectively evaluate the comparative effectiveness His or Left bundle branch pacing (His/LBBP) vs. biventricular pacing (BiVP) in patients with heart failure due to left ventricular systolic dysfunction (LVEF≤50%) and with either a wide QRS (≥130 ms) or with/anticipated >40% pacing who are already receiving current standard heart failure pharmacological therapy by assessing all cause death and heart failure hospitalization at the end of the study.

Additional formal secondary objectives include evaluation disease-specific quality and psychological adjustment changes at 1 year after device implant and evaluation of a composite of death of any cause or heart failure hospitalization or more >15% increase in the left ventricular end-systolic volume index at the end of the study.

Connect with a study center

  • University of Calgary

    Calgary,
    Canada

    Active - Recruiting

  • Waterloo Wellington Cardiovascular Research Institute (WWCRI) - St. Mary's General Hospital

    Kitchener,
    Canada

    Active - Recruiting

  • Research Institute of the McGill University Health Centre (RI-MUHC) - MUHC, Montreal General Hospital

    Montréal,
    Canada

    Active - Recruiting

  • Rush University

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Lovelace Medical Center

    Albuquerque, New Mexico 87102
    United States

    Active - Recruiting

  • Novant Health

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Geisinger Commonwealth School of Medicine

    Scranton, Pennsylvania 18510
    United States

    Active - Recruiting

  • University of Virginia Health System

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • Sentara Healthcare

    Newport News, Virginia 23606
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia 23284
    United States

    Active - Recruiting

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