Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2136 participants
INTERVENTIONAL
2023-09-13
2029-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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%.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Utah
OTHER
Virginia Commonwealth University
OTHER
Cleveland Clinic Florida
OTHER
East Carolina University
OTHER
Baylor College of Medicine
OTHER
Responsible Party
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Mihail Gabriel Chelu
Associate Professor
Principal Investigators
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Mihail G Chelu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Kenneth A Ellenbogen, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Nusrat Jahan
Role: primary
Shahram Sarrafi
Role: primary
Zinai Tellez
Role: primary
Darren N Crawford
Role: primary
Mckenna Krall
Role: primary
Grace E Hughes
Role: primary
Katie L Sullivan
Role: primary
Linette Klevan
Role: primary
Melissa Sears
Role: primary
Nirav Bhagat
Role: primary
Mary Radyk
Role: primary
Fiorella Rafti
Role: primary
Other Identifiers
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PLACER 2021C3- 24160
Identifier Type: -
Identifier Source: org_study_id
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