Physiologic Pacing for Symptomatic First-Degree Heart Block

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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).

Study Overview

Start Date
October 1, 2023
Completion Date
June 30, 2025
Enrollment
40
Date Posted
February 7, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Ascension Saint Thomas Midtown
Nashville, Tennessee 37203, United States

Eligibility

Minimum Age (years)
18
Eligibility Criteria
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)

Study Contact Info

Study Contact Name
Daniel Kaiser, MD; Tonya Fambrough, RN
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
Yes
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.
NCTid (if applicable)
NCT06245304