His-Bundle Corrective Pacing in Heart Failure

ID#: NCT05265520

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: December 02, 2022

End Date: July 01, 2028

Contact Information:
Ann Colasurdo
585-275-1054
Mary Brown
585-273-5283
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).
Eligibility:

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
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