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His-Bundle Corrective Pacing in Heart Failure

This study is looking at two ways to improve heart function in people with heart failure and a specific heart rhythm problem called Right Bundle-Branch Block (RBBB). Researchers are comparing His-CRT implantation, which paces the heart directly through its natural electrical system, to BIV-CRT implantation, which paces both lower chambers of the heart. The goal is to see which method better improves how well the heart pumps blood (measured by Left Ventricular Ejection Fraction) after 6 months. You might be able to join if you are 18 or older, have heart failure, and meet specific guidelines for a CRT-D implant. The study's current status is unclear.

Study design
This is a prospective, randomized, multi-center clinical trial planning to enroll 120 participants.
What's involved
Participants will undergo either a His-CRT implantation or a BIV-CRT implantation procedure. They will have assessments at 6, 12, and 24 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after treatment, with assessments at 6, 12, and 24 months.

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

NCT05265520

His-Bundle Corrective Pacing in Heart Failure

Recruiting
NAAges 18+InterventionalTreatment
University of Rochester
~120 participants
Updated 2026-02-09 on ClinicalTrials.gov
What's tested:His-CRT implantationBIV-CRT implantation

At a glance

Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Left Ventricular Ejection Fraction at 6 months with His-CRT vs. BIV-CRT, in heart failure patients with Right bundle branch block (RBBB)
Measured over 6 month

Conditions

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

Explore related trials

Heart FailureRight bundle branch block

NCT05265520

Where you'd take part

This study runs at 14 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cedars-Sinai Medical Center

    Los Angeles, Californiano site contact published

    Recruiting

  • Geisinger Wyoming Valley

    Wilkes-Barre, Pennsylvaniano site contact published

    Recruiting

  • Mission Health

    Asheville, North Carolinano site contact published

    Recruiting

  • Mount Sinai Hospital

    New York, New Yorkno site contact published

    Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinoisno site contact published

    Recruiting

  • Rush University Medical Center

    Chicago, Illinoisno site contact published

    Recruiting

  • University of Arizona

    Phoenix, Arizonano site contact published

    Recruiting

  • University of Chicago

    Chicago, Illinoisno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Valentina Kutyifa, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Rochester
  • Roderick Tung, MD · PRINCIPAL_INVESTIGATOR · University of Arizona

Who to contact

Ann Colasurdo
[email protected]
585-275-1054
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Left Ventricular Ejection Fraction at 6 months with His-CRT vs. BIV-CRT, in heart failure patients with Right bundle branch block (RBBB)6 month

    The effect of His-CRT vs. BIV-CRT on left ventricular ejection fraction (as a percentage) measured during an echocardiography imaging study will be analyzed using an analysis of covariance model for changes in LVEF from pre-implantation (baseline) to post-implantation (6 months follow-up), with randomized treatment group as the factor of interest, and baseline LVEF as a covariate. A t-test will be performed using this model to compare the adjusted group means, and a confidence interval will be constructed for their difference.