Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in South Korea / NCT07464041
Active, not recruiting Not applicable

Left Bundle Branch Area Pacing Versus Right Ventricular Pacing in Atrioventricular Block With Preserved Ejection Fraction

NCT07464041 · tracked via the Priya Life Science South Korea tracker
Sponsor
Samsung Medical Center
Phase
Not applicable
Started
2024-04-29
Last updated
2026-07-28

Condition(s) studied

Atrioventricular BlockLeft Bunde Branch Area PacingConduction System Pacing

Investigational drug(s) / intervention(s)

Left Bundle Branch Area PacingRight venticular pacing

Left Bundle Branch Area Pacing: 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.

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

Study 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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 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% Exclusion Criteria: * 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)

Primary outcome measure(s)

  • LV ejection fraction — at 1 years after PPM implantation
    % at echocardiography

Trial sites (4)

FacilityCityRegionStatus
Wonju Severance Christian Hospital Wŏnju Gangwon-do
Samsung Medical Center Seoul Seoul
Samsung Changwon Hospital Changwon South Korea
Veterans Health Service Medical Center Seoul South Korea

More Samsung Medical Center trials in South Korea

IVUS Versus FFR for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute MI Recruiting
Genomic Profiling of Pancreatic Cystic Tumors Starting soon
Head and Neck Cancer Omics/Integrated Precision Medicine (HOPE) Recruiting
Korean Stroke Cohort for Functioning and Rehabilitation-II Active, not recruiting
Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer Recruiting

Other trials for the same condition

PReventive Effect Of Left Bundle Branch Area Pacing Versus righT vEntricular paCing on All Cause deaTh, Heart Failure Progression, and Ventricular dysSYNChrony in Patients With Substantial Ventricular Pacing (PROTECT-SYNC): Multicenter Prospective Randomized Controlled Trial Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07464041 on ClinicalTrials.gov ↗ ← All trials in South Korea