Left vs Left Randomized Clinical Trial for Heart Failure

This study is comparing two types of pacing devices for people with heart failure (when your heart can't pump enough blood) and a reduced ejection fraction (LVEF ≤ 50%, meaning your heart's main pumping chamber isn't squeezing as well as it should). The devices are His/Left Bundle Branch Pacing (His/LBBP) and Biventricular Pacing (BiVP). Researchers want to see which one is better at improving your quality of life, physical activity, and reducing hospital stays for heart failure or death. You might be able to join if you are 18 or older, have heart failure with reduced ejection fraction, and a wide QRS (a measurement from an ECG, or heart tracing) or are expected to need a lot of right ventricular pacing. The study will look at these outcomes over 5.5 years. The current recruitment status is unclear.

Study design: This is a randomized, multi-center study comparing two different pacing devices. It plans to enroll 2136 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 5.5 years to assess combined clinical outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Left vs Left Randomized Clinical Trial

Recruiting

NAAges 18+InterventionalTreatment

Baylor College of Medicine

~2,136 participants

Updated 2025-10-02 on ClinicalTrials.gov

What's tested:His/LBBPBiVP

At a glance

Recruiting sites

62 of 71 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

A combined clinical endpoint of all-cause mortality and hospitalization for heart failure

Measured over 5.5 years

Conditions

Heart Failure

Heart Failure With Reduced Ejection Fraction

AV Block

LBBB

RBBB

Intraventricular Conduction Delay

Pacing-Induced Cardiomyopathy

Where it's being run

71 sites across 30 states

Pennsylvania8

Florida6

Illinois4

New Jersey4

Virginia4

Ontario4

Canada4

New York3

Study leadership

Mihail G Chelu, MD, PhD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
Kenneth A Ellenbogen, MD · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University

Who to contact

Mihail G Chelu, MD, PhD

[email protected]

7137987291

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Eligibility criteria

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

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.

What this trial measures

A combined clinical endpoint of all-cause mortality and hospitalization for heart failure5.5 years
The primary efficacy outcome will be described using Kaplan-Meier freedom from event curves over time, with event-free survival compared between assigned treatment arms using a logrank test, stratified by levels of the two factors (LVEF (≤35% vs. 36 to 50%) and conduction abnormality (LBBB vs non-LBBB)) used for randomization.

Trialytics