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

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.

Conditions

• Sick Sinus Syndrome
• Atrioventricular Nodal Dysfunction

Interventions

DEVICE

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 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.

DEVICE

MVP

* 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.

Sponsors & Collaborators

• Severance Hospital

  collaborator OTHER

• Samsung Medical Center

  collaborator OTHER

• Seoul National University Hospital

  collaborator OTHER

• Asan Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-02

Primary Completion

2029-01-31

Completion

2029-01-31

Countries

• South Korea

Study Locations