Overview
The purpose of this study is to determine if physiologic pacing will improve symptoms and outcomes in patients with symptomatic first-degree heart block (pr interval ≥250ms).
Description
The purpose of this study is to determine if physiologic pacing will improve symptoms and outcomes in patients with symptomatic first-degree heart block (pr interval ≥250ms). Patient will undergo a comparative effectiveness study where patients with symptomatic first-degree heart block (pr interval ≥250ms) undergo left bundle pacing (3830 lead) and are randomized to DDD-50 vs Managed Ventricular pacing-50 (MVP-50; AAI-DDD 50) and undergo a crossover at 3 months. This study will compare two standard of care options utilizing Food and Drug Administration (FDA) approved devices. Patients are evaluated at baseline, 3 months, and 6 months in terms of patient symptoms, exercise capacity, arrhythmia burden, and patient activity.
Eligibility
Inclusion Criteria:
- Aged 18 or above
- Ventricular Ejection Fraction (EF) > 50%
- New York Heart Association (NYHA) class II-IV
- PR interval ≥250ms
- Narrow QRS duration (≤140ms) or prolonged QRS duration with typical Right Bundle Branch Block (RBBB) morphology on 12 lead ECG and sinus rhythm
Exclusion Criteria:
- Permanent atrial fibrillation (AF)
- Patients who are unable to perform a 6 minute hall walk
- Other serious medical condition with life expectancy of less than 1 year
- Lack of capacity to consent
- Pregnancy
- Contraindication to use of the relevant study device or leads (as per current manuals from manufacturer)