Physiologic Pacing for Symptomatic First-Degree Heart Block

RECRUITING

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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).

Conditions:

🦠 Symptomatic First-degree Heart Block

🗓️ Study Start (Actual) 1 October 2023

🗓️ Primary Completion (Estimated) 31 December 2024

✅ Study Completion (Estimated) 30 June 2025

👥 Enrollment (Estimated) 40

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Nashville, Tennessee, United States

📋 Eligibility Criteria

Description

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)

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 14 January 2024
First Submitted that Met QC Criteria 29 January 2024
First Posted 7 February 2024

Study Record Updates

Last Update Submitted that Met QC Criteria 29 January 2024
Last Update Posted 7 February 2024
Last Verified January 2024