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Left vs Left Randomized Clinical Trial

NCT05650658 · Baylor College of Medicine
In plain English

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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
About this study
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.
Eligibility criteria
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
Enrollment target: 2136 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2023-09-13
Estimated completion: 2029-06-30
Last updated: 2025-10-02
Interventions
Device: His/LBBPDevice: BiVP
Primary outcomes
  • A combined clinical endpoint of all-cause mortality and hospitalization for heart failure (5.5 years)
Sponsor
Baylor College of Medicine · other
With: Patient-Centered Outcomes Research Institute, University of Utah, Virginia Commonwealth University, Cleveland Clinic Florida, East Carolina University
Contacts & investigators
ContactMihail G Chelu, MD, PhD · contact · leftvsleft@bcm.edu · 7137987291
ContactMerin Thomas · contact · merin.thomas@bcm.edu · 7137987291
InvestigatorMihail G Chelu, MD, PhD · principal_investigator, Baylor College of Medicine
InvestigatorKenneth A Ellenbogen, MD · principal_investigator, Virginia Commonwealth University
All locations (71)
Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZRecruiting
Gilbert, Arizona, United States
University of Arizona College of Medicine- PhoenixRecruiting
Tucson, Arizona, United States
University of Arkansas for Medical Sciences (UAMS)Recruiting
Little Rock, Arkansas, United States
University of California San DiegoRecruiting
La Jolla, California, United States
University of Colorado (Anschutz Medical Campus)Recruiting
Denver, Colorado, United States
South Denver Cardiology AssociatesRecruiting
Littleton, Colorado, United States
Hartford HospitalRecruiting
Hartford, Connecticut, United States
Yale UniversityRecruiting
New Haven, Connecticut, United States
Heart Rhythm SolutionsRecruiting
Davie, Florida, United States
University of Florida JacksonvilleNot Yet Recruiting
Jacksonville, Florida, United States
Mount Sinai Medical Center of Florida, Inc.Not Yet Recruiting
Miami Beach, Florida, United States
Cleveland Clinic FloridaRecruiting
Palm Beach Gardens, Florida, United States
Florida Heart and Vascular, LLC dba Florida Heart Rhythm Specialist, PLLCNot Yet Recruiting
South Pasadena, Florida, United States
University of South FloridaRecruiting
Tampa, Florida, United States
Rush UniversityRecruiting
Chicago, Illinois, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
Northwestern UniversityRecruiting
Evanston, Illinois, United States
CIS Clinical Research CorporationEnrolling By Invitation
Naperville, Illinois, United States
Trustees of Indiana UniversityRecruiting
Indianapolis, Indiana, United States
Baptist Health LouisvilleRecruiting
Louisville, Kentucky, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
HMH Hospitals CorporationRecruiting
Hackensack, New Jersey, United States
Virtua HealthRecruiting
Marlton, New Jersey, United States
Newark Beth Israel Medical CenterRecruiting
Newark, New Jersey, United States
The Valley Hospital, Inc.Recruiting
Ridgewood, New Jersey, United States
Lovelace Medical CenterRecruiting
Albuquerque, New Mexico, United States
Weill Cornell MedicineRecruiting
New York, New York, United States
Icahn School of Medicine at Mount SinaiRecruiting
New York, New York, United States
Columbia University Medical Center/New York-Presbyterian Hospital (CUMC/NYPH)Not Yet Recruiting
New York, New York, United States
MH Mission Hospital LLLP- Asheville Cardiology AssociatesRecruiting
Asheville, North Carolina, United States
University of North CarolinaRecruiting
Chapel Hill, North Carolina, United States
Novant HealthRecruiting
Charlotte, North Carolina, United States
The Christ HospitalRecruiting
Cincinnati, Ohio, United States
The MetroHealth SystemRecruiting
Cleveland, Ohio, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Oregon Health & Science UniversityRecruiting
Portland, Oregon, United States
St. Luke's University Health NetworkRecruiting
Allentown, Pennsylvania, United States
Lehigh Valley Hospital Inc.Recruiting
Allentown, Pennsylvania, United States
Penn Medicine Lancaster GeneralRecruiting
Lancaster, Pennsylvania, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Thomas Jefferson University HospitalRecruiting
Philadelphia, Pennsylvania, United States
Allegheny-Singer Research InstituteRecruiting
Pittsburgh, Pennsylvania, United States
University of PittsburgRecruiting
Pittsburgh, Pennsylvania, United States
Geisinger Commonwealth School of MedicineRecruiting
Scranton, Pennsylvania, United States
Medical University of South Carolina (MUSC)Recruiting
Charleston, South Carolina, United States
Prisma Health-UpstateNot Yet Recruiting
Greenville, South Carolina, United States
Texas Health Research & Education InstituteNot Yet Recruiting
Arlington, Texas, United States
Baylor College of MedicineRecruiting
Houston, Texas, United States
St. Mark's HospitalRecruiting
Salt Lake City, Utah, United States
University of VermontRecruiting
Burlington, Vermont, United States
University of Virginia Health SystemRecruiting
Charlottesville, Virginia, United States
Inova Heart and Vascular InstituteRecruiting
Falls Church, Virginia, United States
Sentara HealthcareRecruiting
Newport News, Virginia, United States
Virginia Commonwealth UniversityRecruiting
Richmond, Virginia, United States
University of WashingtonRecruiting
Seattle, Washington, United States
Mazankowski Alberta Heart Institute/University of AlbertaNot Yet Recruiting
Edmonton, Alberta, Canada
University of British ColumbiaRecruiting
Vancouver, British Columbia, Canada
Victoria Cardiac Arrhythmia Trials (VCAT) Inc.Recruiting
Victoria, British Columbia, Canada
Nova Scotia Health AuthorityRecruiting
Halifax, Nova Scotia, Canada
Hamilton Health Sciences (HHS)Recruiting
Hamilton, Ontario, Canada
Newmarket Electrophysiology Research Group Inc. (NERG)Recruiting
Newmarket, Ontario, Canada
University of Ottawa Heart InstituteRecruiting
Ottawa, Ontario, Canada
Sunnybrook Research InstituteRecruiting
Toronto, Ontario, Canada
Montreal Heart InstituteRecruiting
Montreal, Quebec, Canada
CIUSSS de l'Estrie - CHUSNot Yet Recruiting
Saint-Jean-sur-Richelieu, Quebec, Canada
University of CalgaryRecruiting
Calgary, Canada
Waterloo Wellington Cardiovascular Research Institute (WWCRI) - St. Mary's General HospitalRecruiting
Kitchener, Canada
Research Institute of the McGill University Health Centre (RI-MUHC) - MUHC, Montreal General HospitalRecruiting
Montreal, Canada
Université LavalRecruiting
Québec, Canada
Left vs Left Randomized Clinical Trial · TrialPath