Left vs Left Randomized Clinical Trial

Recruiting now · Not applicable

Conditions studied: Heart Failure, Heart Failure With Reduced Ejection Fraction, AV Block, LBBB, RBBB, Intraventricular Conduction Delay, Pacing-Induced Cardiomyopathy

In brief

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.

Key facts

Study ID

NCT05650658

Run by

Baylor College of Medicine

People needed

2136

Starts

2023-09-13

Expected to finish

2029-06-30

Last updated by the study team

2025-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Valley Hospital, Inc. — Ridgewood, New Jersey, United States (enrolling)
• Lovelace Medical Center — Albuquerque, New Mexico, United States (enrolling)
• Newark Beth Israel Medical Center — Newark, New Jersey, United States (enrolling)
• Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ — Gilbert, Arizona, United States (enrolling)
• University of Arkansas for Medical Sciences (UAMS) — Little Rock, Arkansas, United States (enrolling)
• Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• University of California San Diego — La Jolla, California, United States (enrolling)
• University of Colorado (Anschutz Medical Campus) — Denver, Colorado, United States (enrolling)
• University of Arizona College of Medicine- Phoenix — Tucson, Arizona, United States (enrolling)
• Cleveland Clinic Florida — Palm Beach Gardens, Florida, United States (enrolling)
• South Denver Cardiology Associates — Littleton, Colorado, United States (enrolling)
• University of South Florida — Tampa, Florida, United States (enrolling)
• Rush University — Chicago, Illinois, United States (enrolling)
• University of Chicago — Chicago, Illinois, United States (enrolling)
• Northwestern University — Evanston, Illinois, United States (enrolling)
• Heart Rhythm Solutions — Davie, Florida, United States (enrolling)
• Trustees of Indiana University — Indianapolis, Indiana, United States (enrolling)
• Baptist Health Louisville — Louisville, Kentucky, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• HMH Hospitals Corporation — Hackensack, New Jersey, United States (enrolling)
• Virtua Health — Marlton, New Jersey, United States (enrolling)
• Weill Cornell Medicine — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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