NCT06049992

STylet-driven vs. LumenlEss Lead in Left-Bundle-Branch Pacing

Stylet-driven vs. Lumenless Lead in Left-Bundle-Branch Pacing Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Puerta de Hierro University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The STYLE-LBBP study aims to compare the efficacy and safety of left-bundle branch pacing between the two types of available pacing leads: lumenless vs stylet-driven.

Detailed description

STYLE-LBBP is a randomized, non-blinded, multicenter clinical trial that compares the efficacy and safety of two types of available pacing leads in conduction system pacing (CSP). Patients referred to CSP who meet the inclusion and exclusion criteria will be enrolled and randomized into two groups: i)Left bundle branch pacing (LBBP) using leads without internal light (Lumenless; Medtronic Selectsecure 3830, Minneapolis, USA) or ii) LBBP with stylet-driven leads (Tendril STS 2088TC, Abbott, Inc., USA; Solia S60, Biotronik, SE \& Co., KG, Germany; Ingevity +, Boston Scientific, Marlborough, MA, USA). Efficacy in terms of achieving LBBP (selective and non-selective left bundle capture criteria) will be measured at implantation and after 24 hours. Complications of the procedure will also be recorded.

Conditions

• Left Bundle-Branch Pacing

Interventions

Type	Name	Description
DEVICE	Pacemaker implantation with conduction system pacing using Lumenless leads	Pacemaker implantation for conduction system pacing will be done using leads without internal lumen (Lumenless; Medtronic Selectsecure 3830, Minneapolis, USA).
DEVICE	Pacemaker implantation with conduction system pacing using Stylet-driven leads	Pacemaker implantation for conduction system pacing will be done using leads with internal lumen and retractable helix (Tendril STS 2088TC, Abbott, Inc., USA; Solia S60, Biotronik, SE \& Co., KG, Germany; Ingevity +, Boston Scientific, Marlborough, MA, USA)

Timeline

• Start date: 2023-09-21
• Primary completion: 2025-09-21
• Completion: 2025-09-22
• First posted: 2023-09-22
• Last updated: 2023-12-29

Locations

2 sites across 1 country: Spain