His-Bundle Corrective Pacing in Heart Failure
University of Rochester
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 (BIV-CRT) in patients with heart failure and right bundle branch block (RBBB).
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- ProcedureHis-CRT implantation
The pathophysiological process is utilized in His-Bundle corrective pacing, resulting in a faster and more homogeneous activation of the heart pacing directly via the intrinsic conduction system of the heart accompanied by a right atrial endocardial lead and a right ventricular endocardial lead.
- ProcedureBIV-CRT implantation
Biventricular cardiac resynchronization therapy has been shown to improve outcomes by delivering synchronized electrical stimuli to the right and left ventricles utilizing an an endocardial right atrial lead, an endocardial right ventricular lead, and an epicardial left ventricular lead implanted in a branch of the coronary sinus.
Locations (14)
- University of ArizonaPhoenix, Arizona
- Cedars-Sinai Medical CenterLos Angeles, California
- University of South FloridaTampa, Florida
- Northwestern Memorial HospitalChicago, Illinois
- Rush University Medical CenterChicago, Illinois
- University of ChicagoChicago, Illinois