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Left vs Left Randomized Clinical Trial
Sponsor: Baylor College of Medicine
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.
Official title: Cardiac Resynchronization Therapy Using His/Left Bundle Branch Pacing vs Biventricular Pacing With a Left Ventricular Epicardial Lead in Patients With Heart Failure (HF) With Left Ventricular Ejection Fraction (LVEF)≤50% and With Either a Wide QRS Complex (>130 ms) or With/Anticipated >40% Pacing Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2136
Start Date
2023-09-13
Completion Date
2029-06-30
Last Updated
2025-10-02
Healthy Volunteers
No
Conditions
Interventions
His/LBBP
Pacing at the level His-Bundle or left bundle branch is used to correct the underlying conduction abnormality, resulting in a faster and more homogeneous activation of the heart pacing directly via the intrinsic conduction system of the heart accompanied by a right atrial endocardial lead and a right ventricular defibrillator endocardial lead for LVEF≤35% and by a right atrial endocardial lead for LVEF 36-50%.
BiVP
Biventricular pacing has been shown to improve outcomes by delivering synchronized electrical stimuli to the right and left ventricles utilizing an an endocardial right atrial lead, an endocardial right ventricular lead, and an epicardial left ventricular lead implanted in a branch of the coronary sinus. For LVEF≤35% a biventricular pacemaker-defibrillator will be implanted while for LVEF 36-50% a biventricular pacemaker will be implanted.
Locations (71)
Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ
Gilbert, Arizona, United States
University of Arizona College of Medicine- Phoenix
Tucson, Arizona, United States
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, United States
University of California San Diego
La Jolla, California, United States
University of Colorado (Anschutz Medical Campus)
Denver, Colorado, United States
South Denver Cardiology Associates
Littleton, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Heart Rhythm Solutions
Davie, Florida, United States
University of Florida Jacksonville
Jacksonville, Florida, United States
Mount Sinai Medical Center of Florida, Inc.
Miami Beach, Florida, United States
Cleveland Clinic Florida
Palm Beach Gardens, Florida, United States
Florida Heart and Vascular, LLC dba Florida Heart Rhythm Specialist, PLLC
South Pasadena, Florida, United States
University of South Florida
Tampa, Florida, United States
Rush University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Northwestern University
Evanston, Illinois, United States
CIS Clinical Research Corporation
Naperville, Illinois, United States
Trustees of Indiana University
Indianapolis, Indiana, United States
Baptist Health Louisville
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
HMH Hospitals Corporation
Hackensack, New Jersey, United States
Virtua Health
Marlton, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
The Valley Hospital, Inc.
Ridgewood, New Jersey, United States
Lovelace Medical Center
Albuquerque, New Mexico, United States
Weill Cornell Medicine
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center/New York-Presbyterian Hospital (CUMC/NYPH)
New York, New York, United States
MH Mission Hospital LLLP- Asheville Cardiology Associates
Asheville, North Carolina, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Novant Health
Charlotte, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
The MetroHealth System
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
St. Luke's University Health Network
Allentown, Pennsylvania, United States
Lehigh Valley Hospital Inc.
Allentown, Pennsylvania, United States
Penn Medicine Lancaster General
Lancaster, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States
University of Pittsburg
Pittsburgh, Pennsylvania, United States
Geisinger Commonwealth School of Medicine
Scranton, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Prisma Health-Upstate
Greenville, South Carolina, United States
Texas Health Research & Education Institute
Arlington, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
St. Mark's Hospital
Salt Lake City, Utah, United States
University of Vermont
Burlington, Vermont, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Inova Heart and Vascular Institute
Falls Church, Virginia, United States
Sentara Healthcare
Newport News, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington
Seattle, Washington, 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