Comparing His and Left Bundle Branch Pacing for Heart Failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ
  Gilbert, Arizona, United States Recruiting
• University of Arizona College of Medicine- Phoenix
  Tucson, Arizona, United States Recruiting
• University of Arkansas for Medical Sciences (UAMS)
  Little Rock, Arkansas, United States Recruiting
• University of California San Diego
  La Jolla, California, United States Recruiting
• University of Colorado (Anschutz Medical Campus)
  Denver, Colorado, United States Recruiting
• South Denver Cardiology Associates
  Littleton, Colorado, United States Recruiting

+21 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Mihail G Chelu, MD, PhD — Baylor College of Medicine
• Study coordinator: Mihail G Chelu, MD, PhD
• Email: leftvsleft@bcm.edu
• Phone: 7137987291

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.