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
Status: Recruiting
Location: See all (71) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
University of Arkansas for Medical Sciences (UAMS)
RECRUITING
Little Rock
Arizona
Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ
RECRUITING
Gilbert
University of Arizona College of Medicine- Phoenix
RECRUITING
Tucson
California
University of California San Diego
RECRUITING
La Jolla
Colorado
University of Colorado (Anschutz Medical Campus)
RECRUITING
Denver
South Denver Cardiology Associates
RECRUITING
Littleton
Connecticut
Hartford Hospital
RECRUITING
Hartford
Yale University
RECRUITING
New Haven
Florida
Heart Rhythm Solutions
RECRUITING
Davie
University of Florida Jacksonville
NOT_YET_RECRUITING
Jacksonville
Mount Sinai Medical Center of Florida, Inc.
NOT_YET_RECRUITING
Miami Beach
Cleveland Clinic Florida
RECRUITING
Palm Beach Gardens
Florida Heart and Vascular, LLC dba Florida Heart Rhythm Specialist, PLLC
NOT_YET_RECRUITING
South Pasadena
University of South Florida
RECRUITING
Tampa
Illinois
Rush University
RECRUITING
Chicago
University of Chicago
RECRUITING
Chicago
Northwestern University
RECRUITING
Evanston
CIS Clinical Research Corporation
ENROLLING_BY_INVITATION
Naperville
Indiana
Trustees of Indiana University
RECRUITING
Indianapolis
Kentucky
Baptist Health Louisville
RECRUITING
Louisville
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Minnesota
Mayo Clinic
RECRUITING
Rochester
North Carolina
MH Mission Hospital LLLP- Asheville Cardiology Associates
RECRUITING
Asheville
University of North Carolina
RECRUITING
Chapel Hill
Novant Health
RECRUITING
Charlotte
New Jersey
HMH Hospitals Corporation
RECRUITING
Hackensack
Virtua Health
RECRUITING
Marlton
Newark Beth Israel Medical Center
RECRUITING
Newark
The Valley Hospital, Inc.
RECRUITING
Ridgewood
New Mexico
Lovelace Medical Center
RECRUITING
Albuquerque
New York
Columbia University Medical Center/New York-Presbyterian Hospital (CUMC/NYPH)
NOT_YET_RECRUITING
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Weill Cornell Medicine
RECRUITING
New York
Ohio
The Christ Hospital
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
The MetroHealth System
RECRUITING
Cleveland
Oregon
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
Lehigh Valley Hospital Inc.
RECRUITING
Allentown
St. Luke's University Health Network
RECRUITING
Allentown
Penn Medicine Lancaster General
RECRUITING
Lancaster
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
University of Pennsylvania
RECRUITING
Philadelphia
Allegheny-Singer Research Institute
RECRUITING
Pittsburgh
University of Pittsburg
RECRUITING
Pittsburgh
Geisinger Commonwealth School of Medicine
RECRUITING
Scranton
South Carolina
Medical University of South Carolina (MUSC)
RECRUITING
Charleston
Prisma Health-Upstate
NOT_YET_RECRUITING
Greenville
Texas
Texas Health Research & Education Institute
NOT_YET_RECRUITING
Arlington
Baylor College of Medicine
RECRUITING
Houston
Utah
St. Mark's Hospital
RECRUITING
Salt Lake City
Virginia
University of Virginia Health System
RECRUITING
Charlottesville
Inova Heart and Vascular Institute
RECRUITING
Falls Church
Sentara Healthcare
RECRUITING
Newport News
Virginia Commonwealth University
RECRUITING
Richmond
Vermont
University of Vermont
RECRUITING
Burlington
Washington
University of Washington
RECRUITING
Seattle
Other Locations
Canada
University of Calgary
RECRUITING
Calgary
Mazankowski Alberta Heart Institute/University of Alberta
NOT_YET_RECRUITING
Edmonton
Nova Scotia Health Authority
RECRUITING
Halifax
Hamilton Health Sciences (HHS)
RECRUITING
Hamilton
Waterloo Wellington Cardiovascular Research Institute (WWCRI) - St. Mary's General Hospital
RECRUITING
Kitchener
Montreal Heart Institute
RECRUITING
Montreal
Research Institute of the McGill University Health Centre (RI-MUHC) - MUHC, Montreal General Hospital
RECRUITING
Montreal
Newmarket Electrophysiology Research Group Inc. (NERG)
RECRUITING
Newmarket
University of Ottawa Heart Institute
RECRUITING
Ottawa
Université Laval
RECRUITING
Québec
CIUSSS de l'Estrie - CHUS
NOT_YET_RECRUITING
Saint-jean-sur-richelieu
Sunnybrook Research Institute
RECRUITING
Toronto
University of British Columbia
RECRUITING
Vancouver
Victoria Cardiac Arrhythmia Trials (VCAT) Inc.
RECRUITING
Victoria
Contact Information
Primary
Mihail G Chelu, MD, PhD
leftvsleft@bcm.edu
7137987291
Backup
Merin Thomas
merin.thomas@bcm.edu
7137987291
Time Frame
Start Date: 2023-09-13
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 2136
Treatments
Active_comparator: His/Left Bundle Branch Pacing (His/LBBP)
Patients with LVEF≤35% at entry will receive a His/LBB defibrillator which includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular ICD lead, and an endocardial His-bundle or left bundle branch pacing lead directly pacing the intrinsic conduction system.~Patients with LVEF 36-50% at entry will receive His/LBB pacemaker which includes implantation of two leads, an endocardial right atrial lead, and an endocardial His-bundle or left bundle branch pacing lead directly pacing the intrinsic conduction system.
Active_comparator: Biventricular Pacing (BiVP)
Patients with LVEF≤35% at entry will receive a BiV defibrillator which includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular ICD lead, and and an epicardial left ventricular lead implanted in a branch of the coronary sinus.~Patients with LVEF 36-50% at entry will receive BiV pacemaker which includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular pacing lead, and and an epicardial left ventricular lead implanted in a branch of the coronary sinus.
Related Therapeutic Areas
Sponsors
Collaborators: Cleveland Clinic Florida, Virginia Commonwealth University, East Carolina University, University of Utah, Patient-Centered Outcomes Research Institute
Leads: Baylor College of Medicine