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 5295903, Arizona 5551752 85297
Gilbert 5295903, Arizona 5551752 85297
University of Arizona College of Medicine- Phoenix
Tucson 5318313, Arizona 5551752 85719
Tucson 5318313, Arizona 5551752 85719
University of Arkansas for Medical Sciences (UAMS)
Little Rock 4119403, Arkansas 4099753 72205
Little Rock 4119403, Arkansas 4099753 72205
University of California San Diego
La Jolla 5363943, California 5332921 92093
La Jolla 5363943, California 5332921 92093
University of Colorado (Anschutz Medical Campus)
Denver 5419384, Colorado 5417618 80217
Denver 5419384, Colorado 5417618 80217
South Denver Cardiology Associates
Littleton 5429032, Colorado 5417618 80124
Littleton 5429032, Colorado 5417618 80124
Hartford Hospital
Hartford 4835797, Connecticut 4831725 06102
Hartford 4835797, Connecticut 4831725 06102
Yale University
New Haven 4839366, Connecticut 4831725 06511
New Haven 4839366, Connecticut 4831725 06511
Heart Rhythm Solutions
Davie 4152820, Florida 4155751 33328
Davie 4152820, Florida 4155751 33328
Cleveland Clinic Florida
Palm Beach Gardens 4167519, Florida 4155751 33418
Palm Beach Gardens 4167519, Florida 4155751 33418
University of South Florida
Tampa 4174757, Florida 4155751 33613
Tampa 4174757, Florida 4155751 33613
Rush University
Chicago 4887398, Illinois 4896861 60612
Chicago 4887398, Illinois 4896861 60612
Contact:
Nusrat Jahan
Nusrat Jahan
University of Chicago
Chicago 4887398, Illinois 4896861 60637
Chicago 4887398, Illinois 4896861 60637
Contact:
Shahram Sarrafi
Shahram Sarrafi
Northwestern University
Evanston 4891382, Illinois 4896861 60208
Evanston 4891382, Illinois 4896861 60208
Trustees of Indiana University
Indianapolis 4259418, Indiana 4921868 46202
Indianapolis 4259418, Indiana 4921868 46202
Baptist Health Louisville
Louisville 4299276, Kentucky 6254925 40207
Louisville 4299276, Kentucky 6254925 40207
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02114
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
Boston 4930956, Massachusetts 6254926 02215
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
Rochester 5043473, Minnesota 5037779 55905
HMH Hospitals Corporation
Hackensack 5098706, New Jersey 5101760 07601
Hackensack 5098706, New Jersey 5101760 07601
Virtua Health
Marlton 4502911, New Jersey 5101760 08053
Marlton 4502911, New Jersey 5101760 08053
Newark Beth Israel Medical Center
Newark 5101798, New Jersey 5101760 07112
Newark 5101798, New Jersey 5101760 07112
The Valley Hospital, Inc.
Ridgewood 5103269, New Jersey 5101760 07450
Ridgewood 5103269, New Jersey 5101760 07450
Lovelace Medical Center
Albuquerque 5454711, New Mexico 5481136 87102
Albuquerque 5454711, New Mexico 5481136 87102
Contact:
Zinai Tellez
Zinai Tellez
Weill Cornell Medicine
New York 5128581, New York 5128638 10021
New York 5128581, New York 5128638 10021
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
New York 5128581, New York 5128638 10029
MH Mission Hospital LLLP- Asheville Cardiology Associates
Asheville 4453066, North Carolina 4482348 28803
Asheville 4453066, North Carolina 4482348 28803
University of North Carolina
Chapel Hill 4460162, North Carolina 4482348 27599
Chapel Hill 4460162, North Carolina 4482348 27599
Novant Health
Charlotte 4460243, North Carolina 4482348 28204
Charlotte 4460243, North Carolina 4482348 28204
Contact:
Darren N Crawford
Darren N Crawford
The Christ Hospital
Cincinnati 4508722, Ohio 5165418 45219
Cincinnati 4508722, Ohio 5165418 45219
The MetroHealth System
Cleveland 5150529, Ohio 5165418 44109
Cleveland 5150529, Ohio 5165418 44109
Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
Cleveland 5150529, Ohio 5165418 44195
Oregon Health & Science University
Portland 5746545, Oregon 5744337 97239
Portland 5746545, Oregon 5744337 97239
St. Luke's University Health Network
Allentown 5178127, Pennsylvania 6254927 18015
Allentown 5178127, Pennsylvania 6254927 18015
Lehigh Valley Hospital Inc.
Allentown 5178127, Pennsylvania 6254927 18103
Allentown 5178127, Pennsylvania 6254927 18103
Penn Medicine Lancaster General
Lancaster 5197079, Pennsylvania 6254927 17603
Lancaster 5197079, Pennsylvania 6254927 17603
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107
Philadelphia 4560349, Pennsylvania 6254927 19107
Contact:
Mckenna Krall
Mckenna Krall
Allegheny-Singer Research Institute
Pittsburgh 5206379, Pennsylvania 6254927 15212
Pittsburgh 5206379, Pennsylvania 6254927 15212
University of Pittsburg
Pittsburgh 5206379, Pennsylvania 6254927 15213
Pittsburgh 5206379, Pennsylvania 6254927 15213
Geisinger Commonwealth School of Medicine
Scranton 5211303, Pennsylvania 6254927 18510
Scranton 5211303, Pennsylvania 6254927 18510
Contact:
Grace E Hughes
Grace E Hughes
Medical University of South Carolina (MUSC)
Charleston 4574324, South Carolina 4597040 29425
Charleston 4574324, South Carolina 4597040 29425
Baylor College of Medicine
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
St. Mark's Hospital
Salt Lake City 5780993, Utah 5549030 84124
Salt Lake City 5780993, Utah 5549030 84124
University of Vermont
Burlington 5234372, Vermont 5242283 05402
Burlington 5234372, Vermont 5242283 05402
University of Virginia Health System
Charlottesville 4752031, Virginia 6254928 22908
Charlottesville 4752031, Virginia 6254928 22908
Contact:
Katie L Sullivan
Katie L Sullivan
Inova Heart and Vascular Institute
Falls Church 4758390, Virginia 6254928 22042
Falls Church 4758390, Virginia 6254928 22042
Sentara Healthcare
Newport News 4776024, Virginia 6254928 23606
Newport News 4776024, Virginia 6254928 23606
Contact:
Linette Klevan
Linette Klevan
Virginia Commonwealth University
Richmond 4781708, Virginia 6254928 23284
Richmond 4781708, Virginia 6254928 23284
Contact:
Melissa Sears
Melissa Sears
University of Washington
Seattle 5809844, Washington 5815135 98195
Seattle 5809844, Washington 5815135 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.