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

NCT07314008 | Recruiting DMC

• 1 other identifier: AMC2024-0579
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  * All cases of mortality after randomization will be counted. * Worsening heart failure includes heart failure hospitalization or urgent heart failure visit (outpatient or emergency department) * Persistent atrial fibrillation is defined when there are at least seven consecutive days with 22 hours of device-recorded AF per day or at least one day with an episode of AF lasting at least 22 hours, which is interrupted by electrical or chemical cardioversion.

  2 years

Secondary Outcomes (8)

• - All cause mortality

  2 years

• - Ischemic stroke or systemic embolism

  2 years

• Heart failure rehospitalization

  2 years

• Any rehospitalization

  2 years

• Rehospitalization from cardiac cause

  2 years

Other Outcomes (3)

• Periprocedural complications

  Periprocedural

• Incidence of subclinical AF with pre-specified durations

  2 years

• Procedural success

  Periprocedural

Study Arms (2)

LBBAP

EXPERIMENTAL

Device: LBBAP

MVP

ACTIVE COMPARATOR

Device: MVP

Interventions

LBBAP DEVICE

* 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.

LBBAP

MVP DEVICE

* 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.

MVP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Asan Medical Center: lead
• Severance Hospital: collaborator
• Samsung Medical Center: collaborator
• Seoul National University Hospital: collaborator

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: January 2, 2026
• Study Start: May 2, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: January 2, 2026

Record last verified: 2025-05

Locations

KR (1)