RecruitingNot Applicable

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

South Korea440 participantsStarted 2025-05-02

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \>18 years old * Sinus node dysfunction with symptoms * Atrioventricular conduction delay (PR interval \> 200ms) Exclusion Criteria: * Subject was unable to provide written informed consent or participate in long-term follow-up. * Permanent atrial fibrillation * Pre-existing cardiac implantable electronic device * Persistent advanced atrioventricular conduction disturbance (2:1 block, Mobitz type II, or 3rd degree) * Mechanical tricuspid valve * Ventricular septal defect or scar * Left ventricular ejection fraction \< 35% who indicated cardiac resynchronization therapy * Previous heart transplantation * Pregnant and/or lactating women * Life expectancy \<2 year * Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of composite of all-cause mortality, heart failure hospitalization and persistent atrial fibrillation

Timeframe: 2 years

Trial details

NCT IDNCT07314008

SponsorAsan Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01-31

View on ClinicalTrials.gov More Sick Sinus Syndrome trials