Evaluating His-Bundle Pacing for Heart Failure Treatment
His-Bundle Corrective Pacing in Heart Failure
This study is testing if a new heart pacing method can help people with heart failure and a specific heart block feel better compared to the standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 14 sites (Phoenix, Arizona and 13 other locations) |
| Trial ID | NCT05265520 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of His-bundle pacing enhanced cardiac resynchronization therapy (His-CRT) against traditional cardiac resynchronization therapy (BIV-CRT) in patients suffering from heart failure and right bundle branch block (RBBB). The study will assess improvements in left ventricular ejection fraction (LVEF) and various biomarkers over a period of 24 months. Participants will be monitored for changes in their functional status and quality of life, providing insights into the mechanisms of benefit from His-CRT. The trial is designed to be prospective and randomized, involving multiple centers to ensure a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with heart failure symptoms and specific ECG criteria indicating the need for cardiac resynchronization therapy.
Not a fit: Patients with left bundle branch block or those on a heart transplant list are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved heart function and quality of life for patients with heart failure and RBBB.
How similar studies have performed: While the approach of His-bundle pacing is gaining interest, this specific comparison with BIV-CRT is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Phoenix, Arizona and 13 other locations
- University of Arizona — Phoenix, Arizona, United States (Recruiting)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- University of South Florida — Tampa, Florida, United States (Recruiting)
- Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- Valley Health System — Ridgewood, New Jersey, United States (Recruiting)
- Weill Cornell Medical College — New York, New York, United States (Recruiting)
- Mount Sinai Hospital — New York, New York, United States (Recruiting)
- Mission Health — Asheville, North Carolina, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Geisinger Wyoming Valley — Wilkes-Barre, Pennsylvania, United States (Recruiting)
- University of Vermont — Burlington, Vermont, United States (Recruiting)
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Valentina Kutyifa, MD, PhD — University of Rochester
- Study coordinator: Ann Colasurdo
- Email: ann.colasurdo@heart.rochester.edu
- Phone: 585-275-1054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.