Left Bundle Branch Versus Minimized Ventricular Pacing in Patients With Sick Sinus Syndrome and Prolonged AV Interval
Recruiting now · Not applicable
Conditions studied: Sick Sinus Syndrome, Atrioventricular Nodal Dysfunction
In brief
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.
Key facts
- Study ID
- NCT07314008
- Run by
- Asan Medical Center
- People needed
- 440
- Starts
- 2025-05-02
- Expected to finish
- 2029-01-31
- Last updated by the study team
- 2026-01-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- >18 years old
- Sinus node dysfunction with symptoms
- Atrioventricular conduction delay (PR interval > 200ms)
You may not qualify if…
- 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
Where it is running
- Asan Medical Center — Seoul, Songpa-gu, South Korea (enrolling)
Full record on ClinicalTrials.gov
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