Left vs Left Randomized Clinical Trial
Purpose
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.
Conditions
- Heart Failure
- Heart Failure With Reduced Ejection Fraction
- AV Block
- LBBB
- RBBB
- Intraventricular Conduction Delay
- Pacing-Induced Cardiomyopathy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ
Gilbert, Arizona 85297
Gilbert, Arizona 85297
University of Arizona College of Medicine- Phoenix
Tucson, Arizona 85719
Tucson, Arizona 85719
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
University of California San Diego
La Jolla, California 92093
La Jolla, California 92093
University of Colorado (Anschutz Medical Campus)
Denver, Colorado 80217
Denver, Colorado 80217
South Denver Cardiology Associates
Littleton, Colorado 80124
Littleton, Colorado 80124
Hartford Hospital
Hartford, Connecticut 06102
Hartford, Connecticut 06102
Heart Rhythm Solutions
Davie, Florida 33328
Davie, Florida 33328
Cleveland Clinic Florida
Palm Beach Gardens, Florida 33418
Palm Beach Gardens, Florida 33418
Rush University
Chicago, Illinois 60612
Chicago, Illinois 60612
Contact:
Nusrat Jahan
Nusrat Jahan
University of Chicago
Chicago, Illinois 60637
Chicago, Illinois 60637
Contact:
Shahram Sarrafi
Shahram Sarrafi
Northwestern University
Evanston, Illinois 60208
Evanston, Illinois 60208
Trustees of Indiana University
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Baptist Health Louisville
Louisville, Kentucky 40207
Louisville, Kentucky 40207
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
HMH Hospitals Corporation
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Newark Beth Israel Medical Center
Newark, New Jersey 07112
Newark, New Jersey 07112
The Valley Hospital, Inc.
Ridgewood, New Jersey 07450
Ridgewood, New Jersey 07450
Lovelace Medical Center
Albuquerque, New Mexico 87102
Albuquerque, New Mexico 87102
Contact:
Zinai Tellez
Zinai Tellez
Weill Cornell Medicine
New York, New York 10021
New York, New York 10021
Icahn School of Medicine at Mount Sinai
New York, New York 10029
New York, New York 10029
MH Mission Hospital LLLP- Asheville Cardiology Associates
Asheville, North Carolina 28803
Asheville, North Carolina 28803
University of North Carolina
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
Novant Health
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
Contact:
Darren N Crawford
Darren N Crawford
The Christ Hospital
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Oregon Health & Science University
Portland, Oregon 97239
Portland, Oregon 97239
St. Luke's University Health Network
Allentown, Pennsylvania 18015
Allentown, Pennsylvania 18015
Lehigh Valley Hospital Inc.
Allentown, Pennsylvania 18103
Allentown, Pennsylvania 18103
Penn Medicine Lancaster General
Lancaster, Pennsylvania 17603
Lancaster, Pennsylvania 17603
University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Contact:
Mckenna Krall
Mckenna Krall
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania 15212
Pittsburgh, Pennsylvania 15212
University of Pittsburg
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Geisinger Commonwealth School of Medicine
Scranton, Pennsylvania 18510
Scranton, Pennsylvania 18510
Contact:
Grace E Hughes
Grace E Hughes
Medical University of South Carolina (MUSC)
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Baylor College of Medicine
Houston, Texas 77030
Houston, Texas 77030
St. Mark's Hospital
Salt Lake City, Utah 84124
Salt Lake City, Utah 84124
University of Vermont
Burlington, Vermont 05402
Burlington, Vermont 05402
University of Virginia Health System
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
Contact:
Katie L Sullivan
Katie L Sullivan
Inova Heart and Vascular Institute
Falls Church, Virginia 22042
Falls Church, Virginia 22042
Sentara Healthcare
Newport News, Virginia 23606
Newport News, Virginia 23606
Contact:
Linette Klevan
Linette Klevan
Virginia Commonwealth University
Richmond, Virginia 23284
Richmond, Virginia 23284
Contact:
Melissa Sears
Melissa Sears
University of Washington
Seattle, Washington 98195
Seattle, Washington 98195
More Details
- NCT ID
- NCT05650658
- Status
- Recruiting
- Sponsor
- Baylor College of Medicine
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.