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NCT05650658NARecruiting

Left vs Left Randomized Clinical Trial

Baylor College of Medicine

Start Date

9/13/2023

Completion Date

6/30/2029

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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 to enrollment OR anticipated right ventricular pacing \>40% OR device in place with right ventricular pacing \> 40%. * Are optimized on HF guideline directed medical therapy according to current HF published guidelines OR patient's physician will make an effort to start all guideline-directed medical therapy and titrate doses up as permitted by the participant clinical status and co-morbidities prior to implantation procedure. Exclusion Criteria: * Women who are pregnant, lactating, or plan to become pregnant during the course of the trial. * Participants with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary, intervention in the next three (3) months. * Enzyme-positive myocardial infarction within the past three (3) months prior to enrollment. * Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/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 6 months. * 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 pretreatment with steroids and/or diphenhydramine. * Participants participating in any other interventional cardiovascular clinical trial. * Participants who would be unable to comply with the study's follow-up visit schedule; or * Participants who had any prior unsuccessful attempt at implantation of biventricular pacing (BiVP), His Bundle Pacing (HBP), or Left Bundle Branch Pacing (LBBP) device.

Interventions

DEVICE

His/LBBP

DEVICE

BiVP

Interested in This Trial?

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Conditions

Heart FailureHeart Failure With Reduced Ejection FractionAV BlockLBBBRBBBIntraventricular Conduction DelayPacing-Induced Cardiomyopathy

Locations

Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ

Gilbert, Arizona 85297

United States

University of Arizona College of Medicine- Phoenix

Tucson, Arizona 85719

United States

University of Arkansas for Medical Sciences (UAMS)

Little Rock, Arkansas 72205

United States

University of California San Diego

La Jolla, California 92093

United States

University of Colorado (Anschutz Medical Campus)

Denver, Colorado 80217

United States

South Denver Cardiology Associates

Littleton, Colorado 80124

United States

Hartford Hospital

Hartford, Connecticut 06102

United States

Yale University

New Haven, Connecticut 06511

United States

Heart Rhythm Solutions

Davie, Florida 33328

United States

University of Florida Jacksonville

Jacksonville, Florida 32211

United States

Mount Sinai Medical Center of Florida, Inc.

Miami Beach, Florida 33140

United States

Cleveland Clinic Florida

Palm Beach Gardens, Florida 33418

United States

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

South Pasadena, Florida 33707

United States

University of South Florida

Tampa, Florida 33613

United States

Rush University

Chicago, Illinois 60612

United States

University of Chicago

Chicago, Illinois 60637

United States

Northwestern University

Evanston, Illinois 60208

United States

CIS Clinical Research Corporation

Naperville, Illinois 60540

United States

Trustees of Indiana University

Indianapolis, Indiana 46202

United States

Baptist Health Louisville

Louisville, Kentucky 40207

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

HMH Hospitals Corporation

Hackensack, New Jersey 07601

United States

Virtua Health

Marlton, New Jersey 08053

United States

Newark Beth Israel Medical Center

Newark, New Jersey 07112

United States

The Valley Hospital, Inc.

Ridgewood, New Jersey 07450

United States

Lovelace Medical Center

Albuquerque, New Mexico 87102

United States

Weill Cornell Medicine

New York, New York 10021

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

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

New York, New York 10032

United States

MH Mission Hospital LLLP- Asheville Cardiology Associates

Asheville, North Carolina 28803

United States

University of North Carolina

Chapel Hill, North Carolina 27599

United States

Novant Health

Charlotte, North Carolina 28204

United States

The Christ Hospital

Cincinnati, Ohio 45219

United States

The MetroHealth System

Cleveland, Ohio 44109

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

St. Luke's University Health Network

Allentown, Pennsylvania 18015

United States

Lehigh Valley Hospital Inc.

Allentown, Pennsylvania 18103

United States

Penn Medicine Lancaster General

Lancaster, Pennsylvania 17603

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania 19107

United States

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania 15212

United States

University of Pittsburg

Pittsburgh, Pennsylvania 15213

United States

Geisinger Commonwealth School of Medicine

Scranton, Pennsylvania 18510

United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina 29425

United States

Prisma Health-Upstate

Greenville, South Carolina 29605

United States

Texas Health Research & Education Institute

Arlington, Texas 76011

United States

Baylor College of Medicine

Houston, Texas 77030

United States

St. Mark's Hospital

Salt Lake City, Utah 84124

United States

University of Vermont

Burlington, Vermont 05402

United States

University of Virginia Health System

Charlottesville, Virginia 22908

United States

Inova Heart and Vascular Institute

Falls Church, Virginia 22042

United States

Sentara Healthcare

Newport News, Virginia 23606

United States

Virginia Commonwealth University

Richmond, Virginia 23284

United States

University of Washington

Seattle, Washington 98195

United States

Mazankowski Alberta Heart Institute/University of Alberta

Edmonton, Alberta

Canada

University of British Columbia

Vancouver, British Columbia

Canada

Victoria Cardiac Arrhythmia Trials (VCAT) Inc.

Victoria, British Columbia

Canada

Nova Scotia Health Authority

Halifax, Nova Scotia

Canada

Hamilton Health Sciences (HHS)

Hamilton, Ontario

Canada

Newmarket Electrophysiology Research Group Inc. (NERG)

Newmarket, Ontario

Canada

University of Ottawa Heart Institute

Ottawa, Ontario

Canada

Sunnybrook Research Institute

Toronto, Ontario

Canada

Montreal Heart Institute

Montreal, Quebec

Canada

CIUSSS de l'Estrie - CHUS

Saint-Jean-sur-Richelieu, Quebec

Canada

University of Calgary

Calgary,

Canada

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

Kitchener,

Canada

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

Montreal,

Canada

Université Laval

Québec,

Canada