Left vs Left Randomized Clinical Trial
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
Interventions
His/LBBP
BiVP
Conditions
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