His-Bundle Corrective Pacing in Heart Failure

Recruiting now · Not applicable

Conditions studied: Right Bundle-Branch Block, Heart Failure, His-bundle Pacing, Cardiac Resynchronization Therapy

In brief

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 heart failure and right bundle branch block (RBBB).

Key facts

Study ID

NCT05265520

Run by

University of Rochester

People needed

120

Starts

2022-12-02

Expected to finish

2028-07-01

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Arizona — Phoenix, Arizona, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• University of South Florida — Tampa, Florida, United States (enrolling)
• Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States (enrolling)
• University of Chicago — Chicago, Illinois, United States (enrolling)
• Valley Health System — Ridgewood, New Jersey, United States (enrolling)
• Weill Cornell Medical College — New York, New York, United States (enrolling)
• Mount Sinai Hospital — New York, New York, United States (enrolling)
• Mission Health — Asheville, North Carolina, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Geisinger Wyoming Valley — Wilkes-Barre, Pennsylvania, United States (enrolling)
• University of Vermont — Burlington, Vermont, United States (enrolling)
• Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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