Physiologic Pacing for Symptomatic First-Degree Heart Block
- Conditions
- Symptomatic First-degree Heart Block
- Interventions
- Device: Dual chamber Medtronic pacemaker implantation.Other: DDD-50 pacing programOther: AAI-DDD 50 pacing program
- Registration Number
- NCT06245304
- Lead Sponsor
- Ascension Health
- Brief Summary
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).
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description DDD-50 followed by AAI-DDD 50 Dual chamber Medtronic pacemaker implantation. Patients will be programmed to DDD-50 first. After 3 months, patients will be programmed to AAI-DDD 50. DDD-50 followed by AAI-DDD 50 DDD-50 pacing program Patients will be programmed to DDD-50 first. After 3 months, patients will be programmed to AAI-DDD 50. DDD-50 followed by AAI-DDD 50 AAI-DDD 50 pacing program Patients will be programmed to DDD-50 first. After 3 months, patients will be programmed to AAI-DDD 50. AAI-DDD 50 followed by DDD-50 DDD-50 pacing program Patients will be programmed to AAI-DDD-50 first. After 3 months, patients will be programmed to DDD 50. AAI-DDD 50 followed by DDD-50 Dual chamber Medtronic pacemaker implantation. Patients will be programmed to AAI-DDD-50 first. After 3 months, patients will be programmed to DDD 50. AAI-DDD 50 followed by DDD-50 AAI-DDD 50 pacing program Patients will be programmed to AAI-DDD-50 first. After 3 months, patients will be programmed to DDD 50.
- Primary Outcome Measures
Name Time Method Quality of Life per the Minnesota Living with Heart Failure Questionnaire (MLHFQ) 6 months after pacemaker implantation. Determine if pacemaker programming influences quality of life based on Minnesota Living with Heart Failure Questionnaire (MLHFQ)
- Secondary Outcome Measures
Name Time Method Exercise capacity 6 months after pacemaker implantation. Determine if pacemaker programming influences exercise capacity (6 minute hall walk, Bruce protocol, or modified Bruce protocol).
Atrial fibrillation burden 6 months after pacemaker implantation. Determine if pacemaker programming influences overall burden of atrial fibrillation.
Patient activity 6 months after pacemaker implantation. Determine if pacemaker programming influences patient activity (as measured by device accelerometer).
Trial Locations
- Locations (1)
Ascension Saint Thomas Midtown
🇺🇸Nashville, Tennessee, United States