RecruitingNot ApplicableNCT07464041

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

Left Bundle Branch Area Pacing With a Stylet-Driven Lead Versus Right Ventricular Pacing in Patients With Atrioventricular Block and Preserved Ejection Fraction: A Multicenter Randomized Trial


Sponsor

Samsung Medical Center

Enrollment

200 participants

Start Date

Apr 29, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Left Bundle Branch Area Pacing and a medical device called Right venticular pacing for people with atrioventricular block, conduction system pacing, and other related conditions. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELeft 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.

DEVICERight venticular pacing

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


Locations(4)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Samsung Medical Center

Seoul, Seoul, South Korea

Samsung Changwon Hospital

Changwon, South Korea

Veterans Health Service Medical Center

Seoul, South Korea

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NCT07464041


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