NCT07464041

Brief Summary

Conventional right ventricular pacing (RVP) has been associated with ventricular dyssynchrony and an increased risk of pacing-induced cardiomyopathy, which may lead to worse clinical outcomes. These adverse effects are more pronounced in patients with pre-existing left ventricular dysfunction. To overcome these limitations, left bundle branch area pacing (LBBAP), which directly engages the cardiac conduction system to preserve physiological ventricular activation, has been increasingly adopted in clinical practice. However, in patients with atrioventricular block and preserved left ventricular ejection fraction (LVEF ≥50%), evidence demonstrating the long-term clinical superiority of LBBAP over conventional RVP remains limited. As a result, both pacing strategies continue to be used in current practice. This multicenter randomized trial aims to compare the efficacy, safety, and lead stability of LBBAP using a stylet-driven extendable screw-in lead versus conventional RVP in patients with atrioventricular block and preserved ejection fraction.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Apr 2024Jun 2027

Study Start

First participant enrolled

April 29, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

March 6, 2026

Last Update Submit

March 6, 2026

Conditions

Atrioventricular BlockLeft Bunde Branch Area PacingConduction System Pacing

Outcome Measures

Primary Outcomes (1)

  • LV ejection fraction

    % at echocardiography

    at 1 years after PPM implantation

Secondary Outcomes (6)

  • all cause death

    at 1 years after PPM implantation

  • Cardiac death

    at 1 years after PPM implantation

  • HF admission

    at 1 years after PPM implantation

  • Lead dislodgement

    at 1 years after PPM implantation

  • T wave alternans

    at 1 years after PPM implantation

  • +1 more secondary outcomes

Study Arms (2)

Left bundle branch area pacing

EXPERIMENTAL

Left bundle branch area pacing performed using a stylet-driven extendable screw-in lead for treatment of atrioventricular block.

Device: Left Bundle Branch Area Pacing

Right ventricular pacing

ACTIVE COMPARATOR

Conventional right ventricular pacing using a transvenous pacing lead for treatment of atrioventricular block.

Device: Right venticular pacing

Interventions

Left Bundle Branch Area PacingDEVICE

Left bundle branch area pacing performed using a stylet-driven extendable screw-in pacing lead to achieve physiological ventricular activation in patients with atrioventricular block.

Left bundle branch area pacing
Right venticular pacingDEVICE

Conventional right ventricular pacing performed with a standard transvenous pacing lead for treatment of atrioventricular block.

Right ventricular pacing

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring permanent pacemaker implantation for the following indications:
  • Third-degree AV block
  • First- or second-degree AV block with an expected ventricular pacing burden ≥40%
  • Atrial fibrillation with slow ventricular response with an expected ventricular pacing burden ≥40%

You may not qualify if:

  • Prior implantation of a cardiac pacemaker or implantable cardioverter-defibrillator
  • Left ventricular ejection fraction ≤50%
  • Indication for cardiac resynchronization therapy
  • Life expectancy ≤1 year (e.g., patients not eligible for heart transplantation due to end-stage heart failure, patients with DNR orders, those receiving hospice care after refusal of life-sustaining treatment, or patients with terminal cancer not eligible for chemotherapy or radiotherapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

RECRUITING

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

RECRUITING

Samsung Changwon Hospital

Changwon, South Korea

RECRUITING

Veterans Health Service Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Atrioventricular Block

Condition Hierarchy (Ancestors)

Heart BlockArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Seung-Jung Park, MD, PhD

CONTACT

82-2-3410-3419orthovics@gmail.com

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
MD, PhD

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 11, 2026

Study Start

April 29, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(4)