His-Bundle Corrective Pacing in Heart Failure
Recruiting · NCT05265520 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Rochester
View the official record on ClinicalTrials.gov →Interventions studied
BIV-CRT implantationHis-CRT implantation
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
14 locations listed across 10 US states.
- University of Arizona - Phoenix, Arizona, United States
- Cedars-Sinai Medical Center - Los Angeles, California, United States
- University of South Florida - Tampa, Florida, United States
- Northwestern Memorial Hospital - Chicago, Illinois, United States
- Rush University Medical Center - Chicago, Illinois, United States
- University of Chicago - Chicago, Illinois, United States
- Valley Health System - Ridgewood, New Jersey, United States
- Weill Cornell Medical College - New York, New York, United States
- Mount Sinai Hospital - New York, New York, United States
- Mission Health - Asheville, North Carolina, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- Geisinger Wyoming Valley - Wilkes-Barre, Pennsylvania, United States
- University of Vermont - Burlington, Vermont, United States
- Virginia Commonwealth University - Richmond, Virginia, United States