Left bundle branch area pacing versus minimized ventricular pacing for sick sinus syndrome with a prolonged PR interval
Comparison of Left Bundle Branch Area Pacing and Minimized Ventricular Pacing in Patients With Sinus Node Dysfunction and Atrioventricular Conduction Delay: A Multicenter, Randomized Controlled Clinical Trial
NA · Asan Medical Center · NCT07314008
This test compares left bundle branch area pacing with minimized ventricular pacing to see which works better for adults with sick sinus syndrome and a long AV (PR) interval.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center (other) |
| Locations | 1 site (Seoul, Songpa-gu) |
| Trial ID | NCT07314008 on ClinicalTrials.gov |
What this trial studies
Adults who need a permanent pacemaker for sick sinus syndrome and a PR interval >200 ms are randomized 1:1 to receive either left bundle branch area pacing (LBBAP) targeting conduction system capture with physiological AV timing or a minimized ventricular pacing (MVP) strategy that prolongs AV intervals to reduce ventricular pacing. Randomization is stratified by history of atrial fibrillation and can occur before or during the implant procedure depending on baseline rhythm. Implantation follows prespecified lead position and sensing/threshold criteria, and patients return for regular follow-up visits to monitor pacing function, device settings, and safety outcomes. The trial also specifically tracks the feasibility and procedural safety of LBBAP in this population.
Who should consider this trial
Good fit: Adults (over 18) with symptomatic sinus node dysfunction who require a permanent pacemaker and have AV conduction delay (PR >200 ms), without permanent AF or pre-existing cardiac implantable devices, are ideal candidates.
Not a fit: Patients with permanent atrial fibrillation, persistent advanced AV block (Mobitz II/3rd degree/2:1), LVEF <35% requiring CRT, mechanical tricuspid valve, ventricular septal defect or scar, or who cannot consent or complete follow-up are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the LBBAP approach could preserve more natural ventricular activation, potentially reducing pacing-related heart dysfunction and improving symptoms compared with minimized ventricular pacing.
How similar studies have performed: Conduction system pacing (His-bundle and left bundle branch pacing) has shown promising physiological and small-scale outcome benefits versus traditional right ventricular pacing, but randomized comparisons directly against MVP strategies remain limited and partly novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>18 years old * Sinus node dysfunction with symptoms * Atrioventricular conduction delay (PR interval \> 200ms) Exclusion Criteria: * 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
Where this trial is running
Seoul, Songpa-gu
- Asan Medical Center — Seoul, Songpa-gu, South Korea (RECRUITING)
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: Sick Sinus Syndrome, Atrioventricular Nodal Dysfunction