Left vs Left Randomized Clinical Trial

Last updated: September 28, 2025
Sponsor: Baylor College of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Hyponatremia

Circulation Disorders

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

  • Mazankowski Alberta Heart Institute/University of Alberta

    Edmonton 5946768, Alberta 5883102
    Canada

    Site Not Available

  • University of British Columbia

    Vancouver 6173331, British Columbia 5909050
    Canada

    Active - Recruiting

  • Victoria Cardiac Arrhythmia Trials (VCAT) Inc.

    Victoria 6174041, British Columbia 5909050
    Canada

    Active - Recruiting

  • Nova Scotia Health Authority

    Halifax 6324729, Nova Scotia 6091530
    Canada

    Active - Recruiting

  • Hamilton Health Sciences (HHS)

    Hamilton 5969782, Ontario 6093943
    Canada

    Active - Recruiting

  • Newmarket Electrophysiology Research Group Inc. (NERG)

    Newmarket 6087701, Ontario 6093943
    Canada

    Active - Recruiting

  • University of Ottawa Heart Institute

    Ottawa 6094817, Ontario 6093943
    Canada

    Active - Recruiting

  • Sunnybrook Research Institute

    Toronto 6167865, Ontario 6093943
    Canada

    Active - Recruiting

  • Montreal Heart Institute

    Montreal 6077243, Quebec 6115047
    Canada

    Active - Recruiting

  • CIUSSS de l'Estrie - CHUS

    Saint-Jean-sur-Richelieu 6138495, Quebec 6115047
    Canada

    Site Not Available

  • University of Calgary

    Calgary,
    Canada

    Site Not Available

  • University of Calgary

    Calgary 5913490,
    Canada

    Active - Recruiting

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

    Kitchener,
    Canada

    Site Not Available

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

    Kitchener 5992996,
    Canada

    Active - Recruiting

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

    Montreal 6077243,
    Canada

    Active - Recruiting

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

    Montréal,
    Canada

    Site Not Available

  • Université Laval

    Québec 6325494,
    Canada

    Active - Recruiting

  • Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ

    Gilbert 5295903, Arizona 5551752 85297
    United States

    Active - Recruiting

  • University of Arizona College of Medicine- Phoenix

    Tucson 5318313, Arizona 5551752 85719
    United States

    Active - Recruiting

  • University of Arkansas for Medical Sciences (UAMS)

    Little Rock 4119403, Arkansas 4099753 72205
    United States

    Active - Recruiting

  • University of California San Diego

    La Jolla 5363943, California 5332921 92093
    United States

    Active - Recruiting

  • University of Colorado (Anschutz Medical Campus)

    Denver 5419384, Colorado 5417618 80217
    United States

    Active - Recruiting

  • South Denver Cardiology Associates

    Littleton 5429032, Colorado 5417618 80124
    United States

    Active - Recruiting

  • Hartford Hospital

    Hartford 4835797, Connecticut 4831725 06102
    United States

    Active - Recruiting

  • Yale University

    New Haven 4839366, Connecticut 4831725 06511
    United States

    Active - Recruiting

  • Heart Rhythm Solutions

    Davie 4152820, Florida 4155751 33328
    United States

    Active - Recruiting

  • University of Florida Jacksonville

    Jacksonville 4160021, Florida 4155751 32211
    United States

    Site Not Available

  • Mount Sinai Medical Center of Florida, Inc.

    Miami Beach 4164143, Florida 4155751 33140
    United States

    Site Not Available

  • Cleveland Clinic Florida

    Palm Beach Gardens 4167519, Florida 4155751 33418
    United States

    Active - Recruiting

  • Florida Heart and Vascular, LLC dba Florida Heart Rhythm Specialist, PLLC

    South Pasadena 4173524, Florida 4155751 33707
    United States

    Site Not Available

  • University of South Florida

    Tampa 4174757, Florida 4155751 33613
    United States

    Active - Recruiting

  • Rush University

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Rush University

    Chicago 4887398, Illinois 4896861 60612
    United States

    Active - Recruiting

  • University of Chicago

    Chicago 4887398, Illinois 4896861 60637
    United States

    Active - Recruiting

  • Northwestern University

    Evanston 4891382, Illinois 4896861 60208
    United States

    Active - Recruiting

  • CIS Clinical Research Corporation

    Naperville 4903279, Illinois 4896861 60540
    United States

    Site Not Available

  • Trustees of Indiana University

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Active - Recruiting

  • Baptist Health Louisville

    Louisville 4299276, Kentucky 6254925 40207
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

  • HMH Hospitals Corporation

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Active - Recruiting

  • Virtua Health

    Marlton 4502911, New Jersey 5101760 08053
    United States

    Active - Recruiting

  • Newark Beth Israel Medical Center

    Newark 5101798, New Jersey 5101760 07112
    United States

    Active - Recruiting

  • The Valley Hospital, Inc.

    Ridgewood 5103269, New Jersey 5101760 07450
    United States

    Active - Recruiting

  • Lovelace Medical Center

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Lovelace Medical Center

    Albuquerque 5454711, New Mexico 5481136 87102
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Columbia University Medical Center/New York-Presbyterian Hospital (CUMC/NYPH)

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Active - Recruiting

  • Weill Cornell Medicine

    New York 5128581, New York 5128638 10021
    United States

    Active - Recruiting

  • Novant Health

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • MH Mission Hospital LLLP- Asheville Cardiology Associates

    Asheville 4453066, North Carolina 4482348 28803
    United States

    Active - Recruiting

  • University of North Carolina

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Active - Recruiting

  • Novant Health

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Active - Recruiting

  • The Christ Hospital

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • The MetroHealth System

    Cleveland 5150529, Ohio 5165418 44109
    United States

    Active - Recruiting

  • Oregon Health & Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Active - Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Geisinger Commonwealth School of Medicine

    Scranton, Pennsylvania 18510
    United States

    Site Not Available

  • Lehigh Valley Hospital Inc.

    Allentown 5178127, Pennsylvania 6254927 18103
    United States

    Active - Recruiting

  • St. Luke's University Health Network

    Allentown 5178127, Pennsylvania 6254927 18015
    United States

    Active - Recruiting

  • Penn Medicine Lancaster General

    Lancaster 5197079, Pennsylvania 6254927 17603
    United States

    Active - Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • Allegheny-Singer Research Institute

    Pittsburgh 5206379, Pennsylvania 6254927 15212
    United States

    Active - Recruiting

  • University of Pittsburg

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Active - Recruiting

  • Geisinger Commonwealth School of Medicine

    Scranton 5211303, Pennsylvania 6254927 18510
    United States

    Active - Recruiting

  • Medical University of South Carolina (MUSC)

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Active - Recruiting

  • Prisma Health-Upstate

    Greenville 4580543, South Carolina 4597040 29605
    United States

    Site Not Available

  • Texas Health Research & Education Institute

    Arlington 4671240, Texas 4736286 76011
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • St. Mark's Hospital

    Salt Lake City 5780993, Utah 5549030 84124
    United States

    Active - Recruiting

  • University of Vermont

    Burlington 5234372, Vermont 5242283 05402
    United States

    Active - Recruiting

  • University of Virginia Health System

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Sentara Healthcare

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23284
    United States

    Site Not Available

  • University of Virginia Health System

    Charlottesville 4752031, Virginia 6254928 22908
    United States

    Active - Recruiting

  • Inova Heart and Vascular Institute

    Falls Church 4758390, Virginia 6254928 22042
    United States

    Active - Recruiting

  • Sentara Healthcare

    Newport News 4776024, Virginia 6254928 23606
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond 4781708, Virginia 6254928 23284
    United States

    Active - Recruiting

  • University of Washington

    Seattle 5809844, Washington 5815135 98195
    United States

    Active - Recruiting

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