🔎 Trials Near Me

Home › Heart Failure › NCT05650658

Left vs Left Randomized Clinical Trial

Recruiting

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

Who can join

Ages 18 and older · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Baylor College of Medicine · Participants: 2,136 · Started: Sep 13, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05650658

Locations in the U.S.

ArizonaMercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ, Gilbert
University of Arizona College of Medicine- Phoenix, Tucson
ArkansasUniversity of Arkansas for Medical Sciences (UAMS), Little Rock
CaliforniaUniversity of California San Diego, La Jolla
ColoradoUniversity of Colorado (Anschutz Medical Campus), Denver
South Denver Cardiology Associates, Littleton
ConnecticutHartford Hospital, Hartford
Yale University, New Haven
FloridaHeart Rhythm Solutions, Davie
University of Florida Jacksonville, Jacksonville (Not yet recruiting)
Mount Sinai Medical Center of Florida, Inc., Miami Beach (Not yet recruiting)
Cleveland Clinic Florida, Palm Beach Gardens
Florida Heart and Vascular, LLC dba Florida Heart Rhythm Specialist, PLLC, South Pasadena (Not yet recruiting)
University of South Florida, Tampa
IllinoisRush University, Chicago
University of Chicago, Chicago
Northwestern University, Evanston
IndianaTrustees of Indiana University, Indianapolis
KentuckyBaptist Health Louisville, Louisville
MassachusettsBeth Israel Deaconess Medical Center, Boston
Massachusetts General Hospital, Boston
MinnesotaMayo Clinic, Rochester
New JerseyHMH Hospitals Corporation, Hackensack
Virtua Health, Marlton
Newark Beth Israel Medical Center, Newark
The Valley Hospital, Inc., Ridgewood
New MexicoLovelace Medical Center, Albuquerque
New YorkColumbia University Medical Center/New York-Presbyterian Hospital (CUMC/NYPH), New York (Not yet recruiting)
Icahn School of Medicine at Mount Sinai, New York
Weill Cornell Medicine, New York
North CarolinaMH Mission Hospital LLLP- Asheville Cardiology Associates, Asheville
University of North Carolina, Chapel Hill
Novant Health, Charlotte
OhioThe Christ Hospital, Cincinnati
Cleveland Clinic, Cleveland
The MetroHealth System, Cleveland
OregonOregon Health & Science University, Portland
PennsylvaniaLehigh Valley Hospital Inc., Allentown
St. Luke's University Health Network, Allentown
Penn Medicine Lancaster General, Lancaster
Thomas Jefferson University Hospital, Philadelphia
University of Pennsylvania, Philadelphia
Allegheny-Singer Research Institute, Pittsburgh
University of Pittsburg, Pittsburgh
Geisinger Commonwealth School of Medicine, Scranton
South CarolinaMedical University of South Carolina (MUSC), Charleston
Prisma Health-Upstate, Greenville (Not yet recruiting)
TexasTexas Health Research & Education Institute, Arlington (Not yet recruiting)
Baylor College of Medicine, Houston
UtahSt. Mark's Hospital, Salt Lake City
VermontUniversity of Vermont, Burlington
VirginiaUniversity of Virginia Health System, Charlottesville
Inova Heart and Vascular Institute, Falls Church
Sentara Healthcare, Newport News
Virginia Commonwealth University, Richmond
WashingtonUniversity of Washington, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.