Compares two pacing methods for heart failure with reduced heart function
Tests His or left bundle branch pacing against biventricular pacing in heart failure patients.
Plain-language title generated from the registry record
Registry title: Left vs Left Randomized Clinical Trial
Key facts
- Where
- Albuquerque, Allentown, Arlington, Asheville, Boston, Burlington, Chapel Hill, Charleston, Charlotte, Charlottesville, Chicago, Cincinnati, Cleveland, Davie, Denver, Evanston, Falls Church, Gilbert, Greenville, Hackensack, Hartford, Houston, Indianapolis, Jacksonville, La Jolla, Lancaster, Little Rock, Littleton, Louisville, Marlton, Miami Beach, Naperville, New Haven, New York, Newark, Newport News, Palm Beach Gardens, Philadelphia, Pittsburgh, Portland, Richmond, Ridgewood, Rochester, Salt Lake City, Scranton, Seattle, South Pasadena, Tampa, and Tucson, United StatesSee the 57 sites
Where in United States
- Lovelace Medical CenterAlbuquerque, United StatesTaking people
- Lehigh Valley Hospital, IncAllentown, United StatesTaking people
- St. Luke's University Health NetworkAllentown, United StatesTaking people
- Texas Health Research & Education InstituteArlington, United StatesNot yet recruiting
- MH Mission Hospital LLLP- Asheville Cardiology AssociatesAsheville, United StatesTaking people
- Beth Israel Deaconess Medical CenterBoston, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- University of VermontBurlington, United StatesTaking people
- University of North CarolinaChapel Hill, United StatesTaking people
- Medical University of South Carolina (MUSC)Charleston, United StatesTaking people
- Novant HealthCharlotte, United StatesTaking people
- University of Virginia Health SystemCharlottesville, United StatesTaking people
- RUSH UniversityChicago, United StatesTaking people
- University of ChicagoChicago, United StatesTaking people
- The Christ HospitalCincinnati, United StatesTaking people
- Cleveland ClinicCleveland, United StatesTaking people
- The MetroHealth SystemCleveland, United StatesTaking people
- Heart Rhythm SolutionsDavie, United StatesTaking people
- University of Colorado (Anschutz Medical Campus)Denver, United StatesTaking people
- Northwestern UniversityEvanston, United StatesTaking people
- Inova Heart and Vascular InstituteFalls Church, United StatesTaking people
- Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZGilbert, United StatesTaking people
- Prisma Health-UpstateGreenville, United StatesNot yet recruiting
- HMH Hospitals CorporationHackensack, United StatesTaking people
- Hartford HospitalHartford, United StatesTaking people
- Baylor College of MedicineHouston, United StatesTaking people
- Trustees of Indiana UniversityIndianapolis, United StatesTaking people
- University of Florida - JacksonvilleJacksonville, United StatesNot yet recruiting
- University of California San DiegoLa Jolla, United StatesTaking people
- Penn Medicine Lancaster GeneralLancaster, United StatesTaking people
- University of Arkansas for Medical Sciences (UAMS)Little Rock, United StatesTaking people
- South Denver Cardiology AssociatesLittleton, United StatesTaking people
- Baptist Health LouisvilleLouisville, United StatesTaking people
- Virtua HealthMarlton, United StatesTaking people
- Mount Sinai Medical Center of Florida, Inc.Miami Beach, United StatesNot yet recruiting
- CIS Clinical Research CorporationNaperville, United StatesEnrolling by invitation
- Yale UniversityNew Haven, United StatesTaking people
- Columbia University Medical Center/New York-Presbyterian Hospital (CUMC/NYPH)New York, United StatesNot yet recruiting
- Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
- Weill Cornell MedicineNew York, United StatesTaking people
- Newark Beth Israel Medical CenterNewark, United StatesTaking people
- Sentara HealthcareNewport News, United StatesTaking people
- Cleveland Clinic FloridaPalm Beach Gardens, United StatesTaking people
- Thomas Jefferson University HospitalPhiladelphia, United StatesTaking people
- University of PennsylvaniaPhiladelphia, United StatesTaking people
- Allegheny-Singer Research InstitutePittsburgh, United StatesTaking people
- University of PittsburgPittsburgh, United StatesTaking people
- Oregon Health Science UniversityPortland, United StatesTaking people
- Virginia Commonwealth UniversityRichmond, United StatesTaking people
- The Valley Hospital Inc.Ridgewood, United StatesTaking people
- Mayo ClinicRochester, United StatesTaking people
- St. Mark's HospitalSalt Lake City, United StatesTaking people
- Geisinger Commonwealth School of MedicineScranton, United StatesTaking people
- University of WashingtonSeattle, United StatesTaking people
- Florida Heart and Vascular, LLC dba Florida Heart Rhythm Specialist, PLLCSouth Pasadena, United StatesNot yet recruiting
- University of South FloridaTampa, United StatesTaking people
- University of Arizona College of Medicine- PhoenixTucson, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Baylor College of Medicine
- Trial code
- NCT05650658
- Record updated
- 2 October 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; Participants who had any prior unsuccessful attempt at implantation of biventricular pacing (BiVP), His Bundle Pacing (HBP), or Left Bundle Branch Pacing (LBBP) device; 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; 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); 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; Women who are pregnant, lactating, or plan to become pregnant during the course of the trial; Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis); Have a life expectancy of less than 12 months; 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.