Comparing two types of pacing leads for heart rhythm management
Stylet-driven vs. Lumenless Lead in Left-Bundle-Branch Pacing Randomized Trial
This study is testing which type of pacing lead works better and is safer for people getting a pacemaker to help manage their heart rhythm.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Puerta de Hierro University Hospital Academic / other |
| Locations | 2 sites (Majadahonda, Madrid and 1 other locations) |
| Trial ID | NCT06049992 on ClinicalTrials.gov |
What this trial studies
The STYLE-LBBP study is a randomized, non-blinded, multicenter clinical trial designed to evaluate the efficacy and safety of two different pacing leads used in left-bundle branch pacing (LBBP). Participants will be randomly assigned to receive either lumenless leads or stylet-driven leads during their pacemaker implantation. The study will assess the success of achieving left bundle branch capture and monitor any complications that arise during the procedure. This research aims to provide insights into which lead type may offer better outcomes for patients requiring conduction system pacing.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are referred for conduction system pacing.
Not a fit: Patients with a prosthetic tricuspid valve will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pacing techniques that enhance heart rhythm management for patients.
How similar studies have performed: While this study explores a specific comparison of pacing leads, similar approaches in conduction system pacing have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Patients referred for conduction system pacing Exclusion Criteria: * Patients with a prosthetic (metal or biologic) tricuspid valve.
Where this trial is running
Majadahonda, Madrid and 1 other locations
- Puerta de Hierro University Hospital — Majadahonda, Madrid, Spain (Recruiting)
- Fundación Jiménez Díaz University Hospital — Madrid, Spain (Not_yet_recruiting)
Study contacts
- Principal investigator: Alvaro Lorente-Ros, MD — Puerta de Hierro University Hospital
- Study coordinator: Alvaro Lorente-Ros, MD
- Email: alvaro.lorente@salud.madrid.org
- Phone: 911916000
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.