His-Bundle Corrective Pacing in Heart Failure
Purpose
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).
Conditions
- Right Bundle-Branch Block
- Heart Failure
- His-bundle Pacing
- Cardiac Resynchronization Therapy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator His-CRT implantation |
His-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an endocardial His-bundle pacing leads directly pacing the intrinsic conduction system. |
|
|
Active Comparator BIV-CRT implantation |
BIV-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an epicardial left ventricular lead implanted in a branch of the coronary sinus. |
|
Recruiting Locations
Chicago, Illinois 60637
Shahram Sarrafi
Paramus, New Jersey 07652
Kim Michel
Burlington, Vermont 05401
Amy Henderson
More Details
- NCT ID
- NCT05265520
- Status
- Recruiting
- Sponsor
- University of Rochester
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 resynchronization therapy (His-CRT) vs. cardiac resynchronization therapy (BIV-CRT) in patients with Right Bundle Branch Block (RBBB) Electrocardiogram (ECG) Pattern by assessing the improvement in left ventricular ejection fraction (LVEF) in the His-CRT vs. BIV-CRT arm at 6 months, and by evaluating changes in ECG biomarkers, NT-pro-brain natriuretic peptide (NT-proBNP) levels, and echocardiography biomarkers (left ventricular volumes, strain contractility, and dyssynchrony), as well as temporal changes in functional status and quality of life in the His-CRT vs. BIV-CRT arm at 6, 12, and 24 months.