Left bundle branch area pacing versus right ventricular pacing for 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
NA · Samsung Medical Center · NCT07464041
This study will test whether left bundle branch area pacing works better than standard right ventricular pacing for people with atrioventricular block who have a normal or preserved ejection fraction (LVEF ≥50%).
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center (other) |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Wŏnju, Gangwon-do and 3 other locations) |
| Trial ID | NCT07464041 on ClinicalTrials.gov |
What this trial studies
This is a multicenter randomized trial comparing left bundle branch area pacing (LBBAP) using a stylet-driven extendable screw-in lead with conventional right ventricular pacing (RVP) in patients who require permanent pacemakers for atrioventricular block and have preserved left ventricular ejection fraction. Participants are randomized to one of the two pacing strategies and followed for safety, lead performance/stability, electrical/hemodynamic measures, and clinical outcomes. Key eligibility excludes prior device implantation, LVEF ≤50%, and indications for cardiac resynchronization therapy. The trial is being conducted at several tertiary hospitals in South Korea with planned long-term follow-up to detect differences in pacing-related complications and cardiac function.
Who should consider this trial
Good fit: Ideal candidates are adults needing a new permanent pacemaker for third-degree AV block, high-burden first- or second-degree AV block, or atrial fibrillation with slow ventricular response who expect a ventricular pacing burden ≥40% and have LVEF ≥50% without prior pacemaker/ICD or a CRT indication.
Not a fit: Patients with reduced left ventricular function (LVEF ≤50%), those who already have a pacemaker or ICD, those needing cardiac resynchronization therapy, or those with life expectancy ≤1 year are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, LBBAP could reduce pacing-related dyssynchrony and the risk of pacing-induced cardiomyopathy, potentially improving long-term heart function and clinical outcomes compared with standard RVP.
How similar studies have performed: Short-term and observational studies of physiological conduction system pacing have shown favorable electrical and haemodynamic effects, but robust long-term randomized evidence—particularly using stylet-driven leads in patients with preserved LVEF—is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Wŏnju, Gangwon-do and 3 other locations
- Wonju Severance Christian Hospital — Wŏnju, Gangwon-do, South Korea (RECRUITING)
- Samsung Medical Center — Seoul, Seoul, South Korea (RECRUITING)
- Samsung Changwon Hospital — Changwon, South Korea (RECRUITING)
- Veterans Health Service Medical Center — Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: Seung-Jung Park, MD, PhD
- Email: orthovics@gmail.com
- Phone: 82-2-3410-3419
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrioventricular Block, Left Bunde Branch Area Pacing, Conduction System Pacing