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Comparing His and Left Bundle Branch Pacing for Heart Failure

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

Not applicable Interventional Baylor College of Medicine · NCT05650658

This study is testing whether a new way of pacing the heart can help people with heart failure feel better and stay out of the hospital compared to the usual treatment.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment2136 (estimated)
Ages18 Years and up
SexAll
SponsorBaylor College of Medicine Academic / other
Locations71 sites (Gilbert, Arizona and 70 other locations)
Trial IDNCT05650658 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of His or Left bundle branch pacing compared to standard biventricular pacing in patients with heart failure due to left ventricular systolic dysfunction. The study will assess patient-centered outcomes such as quality of life, physical activity, heart failure hospitalizations, and mortality, as well as safety outcomes related to device complications. Participants will be randomized and monitored over time to determine the best pacing strategy for improving heart failure management.

Who should consider this trial

Good fit: Ideal candidates include men and women aged 18 and older with heart failure, a left ventricular ejection fraction of 50% or less, and a wide QRS duration.

Not a fit: Patients with significant coronary artery disease requiring revascularization or those who are pregnant or lactating may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved heart failure management and better quality of life for patients through optimized pacing techniques.

How similar studies have performed: Other studies have shown promising results with similar pacing approaches, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Gilbert, Arizona and 70 other locations

+21 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart FailureHeart Failure With Reduced Ejection FractionAV BlockLBBBRBBBIntraventricular Conduction DelayPacing-Induced Cardiomyopathy
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.