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His-Bundle Corrective Pacing in Heart Failure | Clinical Trials | Clareo Health

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RECRUITINGNANCT05265520

His-Bundle Corrective Pacing in Heart Failure

The investigators aim to prospectively evaluate the efficacy and mechanism of benefit of His-bundle pacing enhanced cardiac resynchronization therapy (His-CRT) vs. cardiac resynchronization therapy (B...

Lead sponsor: University of Rochester•14 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Ann Colasurdo

CONTACT

585-275-1054 ann.colasurdo@heart.rochester.edu

Mary Brown

CONTACT

585-273-5283 mary.brown@heart.rochester.edu

Sponsors

Lead Sponsor

University of Rochester

Collaborators

National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)

In this prospective, randomized, multi-center clinical trial, the investigators aim to prospectively evaluate the efficacy and mechanism of benefit of His-bundle pacing enhanced cardiac resynchronization therapy (His-CRT) vs. cardiac resynchronization therapy (BIV-CRT) in patients with Right Bundle Branch Block (RBBB) Electrocardiogram (ECG) Pattern by assessing the improvement in left ventricular ejection fraction (LVEF) in the His-CRT vs. BIV-CRT arm at 6 months, and by evaluating changes in ECG biomarkers, NT-pro-brain natriuretic peptide (NT-proBNP) levels, and echocardiography biomarkers (left ventricular volumes, strain contractility, and dyssynchrony), as well as temporal changes in functional status and quality of life in the His-CRT vs. BIV-CRT arm at 6, 12, and 24 months.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Age 18 years or older (no upper age limit)
•Optimal medical therapy for heart failure by current guidelines
•Class IIa or IIb guideline-based indication for CRT-D implant in RBBB patients, including one of the following:
•* New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb); OR
•* NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa); OR
•* NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration 120-149 ms (IIb)

Exclusion Criteria

•Unable to obtain most recent imaging data from echocardiogram within 1 year prior to date of randomization
•Left bundle branch block (LBBB) or intraventricular conduction delay (IVCD) ECG morphology
•Unable or unwilling to follow study protocol
•Less than 12 months life expectancy at consent
•Pregnancy or planned pregnancy during duration of the study
•On heart transplant list or likely to undergo heart transplant

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 9, 2026Terms

Trial snapshot

StatusRECRUITING

PhaseNA

Enrollment120

Start dateDec 2022

Last updatedFeb 9, 2026

Condition

Right Bundle-Branch Block Heart Failure His-bundle Pacing Cardiac Resynchronization Therapy

Locations shown

University of Arizona

Phoenix, Arizona

Cedars-Sinai Medical Center

Los Angeles, California

University of South Florida

Tampa, Florida

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2026Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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