Status:
RECRUITING
His-Bundle Corrective Pacing in Heart Failure
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Right Bundle-Branch Block
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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 resynchronizat...
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
Key Trial Info
Start Date :
December 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05265520
Start Date
December 2 2022
End Date
July 1 2027
Last Update
March 7 2025
Active Locations (3)
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1
University of Chicago
Chicago, Illinois, United States, 60637
2
Valley Health System
Paramus, New Jersey, United States, 07652
3
University of Vermont
Burlington, Vermont, United States, 05401