Left Bundle Branch Versus Minimized Ventricular Pacing in Patients With Sick Sinus Syndrome and Prolonged AV Interval
Comparison of Left Bundle Branch Area Pacing and Minimized Ventricular Pacing in Patients With Sinus Node Dysfunction and Atrioventricular Conduction Delay: A Multicenter, Randomized Controlled Clinical Trial
Asan Medical Center
440 participants
May 2, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- >18 years old
- Sinus node dysfunction with symptoms
- Atrioventricular conduction delay (PR interval > 200ms)
Exclusion Criteria11
- 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
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Interventions
* All pacemaker implantation should be performed in standard manner. * A lead should be placed in the right atrial appendage or septum where acceptable sensing (P wave \>1mV) and pacing threshold (\<1V at 0.4ms width). * V lead should be placed in the right ventricular septum where conduction system pacing can be achieved with acceptable sensing and pacing threshold. The pacing morphology should be compatible with His bundle pacing, right ventricular pacing, selective and non-selective left bundle branch pacing, or left fascicular pacing. * The primary objective for the LBBAP group is the achievement of conduction system capture with LBBAP. However, based on the physician's discretion or the situations in the operating room, His bundle pacing can be accepted as alternatives to LBBAP.
* All pacemaker implantation should be performed in standard manner. * A lead should be placed in the right atrial appendage or septum where acceptable sensing (P wave \>1mV) and pacing threshold (\<1V at 0.4ms width). * V lead should be placed in the right ventricular apex or septum where acceptable sensing (R wave \>5mV) and pacing threshold (\<1V at 0.4ms width) * The rhythmiQTM mode should be turned on * Sensing and pacing AV intervals recommended to be \>300ms (default value or more), and should not be \<200ms to minimize the ventricular pacing.
Locations(1)
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NCT07314008