Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07314008

Left Bundle Branch Versus Minimized Ventricular Pacing in Patients With Sick Sinus Syndrome and Prolonged AV Interval

Led by Asan Medical Center · Updated on 2026-01-02

440

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

Sponsors

A

Asan Medical Center

Lead Sponsor

S

Severance Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to compare two pacemaker strategies: Left Bundle Branch Area Pacing (LBBAP) and Minimized Ventricular Pacing (MVP) in patients requiring a permanent pacemaker for sick sinus syndrome and prolonged AV interval. It will also evaluate the safety and feasibility of the LBBAP method in these patients. The main questions it aims to answer is: \*Is LBBAP with physiological AV interval better than Minimized Ventricular Pacing? Researchers will compare the LBBAP group (aiming for conduction system capture with physiological AV intervals) to the MVP group (aiming to minimize ventricular pacing with prolonged AV intervals) to evaluate the optimal pacing strategy. Participants will: * Be randomly assigned to either the LBBAP group or the MVP group. * Undergo a pacemaker implantation procedure according to the specific criteria for their assigned group. * Visit the clinic for regular checkups to measure pacing function and ensure the device settings remain compliant with the study protocol.

CONDITIONS

Official Title

Left Bundle Branch Versus Minimized Ventricular Pacing in Patients With Sick Sinus Syndrome and Prolonged AV Interval

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Diagnosed with sinus node dysfunction with symptoms
  • Atrioventricular conduction delay with PR interval greater than 200 milliseconds
Not Eligible

You will not qualify if you...

  • Unable to provide written informed consent or participate in long-term follow-up
  • Permanent atrial fibrillation
  • Already have a cardiac implantable electronic device
  • Persistent advanced atrioventricular conduction disturbances like 2:1 block, Mobitz type II, or 3rd degree block
  • Presence of mechanical tricuspid valve
  • Ventricular septal defect or scar
  • Left ventricular ejection fraction less than 35% requiring cardiac resynchronization therapy
  • Previous heart transplantation
  • Pregnant or breastfeeding women
  • Life expectancy less than 2 years
  • Currently participating in another investigational drug or device study without completed primary endpoint follow-up

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Trial Site Locations

Total: 1 location

1

Asan Medical Center

Seoul, Songpa-gu, South Korea, 05505

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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