Actively Recruiting
Left Bundle Branch Area Pacing With a Stylet-Driven Lead Versus Right Ventricular Pacing in Patients With Atrioventricular Block and Preserved Ejection Fraction: A Multicenter Randomized Trial
Led by Samsung Medical Center · Updated on 2026-03-11
200
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of left bundle branch area pacing (LBBAP) versus conventional right ventricular pacing (RVP) in patients with atrioventricular block who have preserved left ventricular ejection fraction (LVEF 60%). This trial aims to compare the efficacy, safety, and lead stability of LBBAP using a stylet-driven extendable screw-in lead against conventional RVP, addressing the limitations of RVP which can cause ventricular dyssynchrony and pacing-induced cardiomyopathy, especially in those with impaired cardiac function. The study involves two treatment groups: one receiving LBBAP with a stylet-driven extendable screw-in pacing lead designed to preserve physiological ventricular activation, and the other receiving conventional RVP using a standard transvenous pacing lead. Both approaches are evaluated as permanent pacemaker implantation strategies for managing atrioventricular block. The comparison focuses on long-term clinical outcomes, including heart function and device lead stability. Participants will be monitored for one year following pacemaker implantation, with assessments including measurements of left ventricular ejection fraction, mortality rates, heart failure admissions, lead dislodgement, electrical activity markers like T wave alternans, and blood biomarkers such as NTproBNP. This comprehensive follow-up is intended to provide detailed information on the benefits and risks of each pacing method, with the total study duration extending to the end date in June 2027.
CONDITIONS
Brief Title
Left Bundle Branch Area Pacing Versus Right Ventricular Pacing in Atrioventricular Block With Preserved Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients requiring permanent pacemaker implantation for third-degree atrioventricular block
- Patients with first- or second-degree atrioventricular block expected to have ventricular pacing 60%
- Patients with atrial fibrillation and slow ventricular response expected to have ventricular pacing 60%
- Age 19 years or older
You will not qualify if you...
- Prior implantation of a cardiac pacemaker or implantable cardioverter-defibrillator
- Left ventricular ejection fraction 50% or less
- Indication for cardiac resynchronization therapy
- Life expectancy of 1 year or less due to severe illness or advanced disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants receive implantation of either left bundle branch area pacing using a stylet-driven extendable screw-in lead or conventional right ventricular pacing with a transvenous pacing lead for treatment of atrioventricular block.
1 implantation visit (in-person)
Duration - Up to 1 year after pacemaker implantation
Participants are monitored for device function, lead stability, and cardiac function after pacing lead implantation.
Approximately 6 follow-up visits (in-person)
Trial Site Locations
Total: 4 locations
1
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
Actively Recruiting
2
Samsung Medical Center
Seoul, Seoul, South Korea, 06351
Actively Recruiting
3
Samsung Changwon Hospital
Changwon, South Korea
Actively Recruiting
4
Veterans Health Service Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
S
Seung-Jung Park, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here