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

Last updated: December 24, 2023
Sponsor: Puerta de Hierro University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Pacemaker implantation with conduction system pacing using Stylet-driven leads

Pacemaker implantation with conduction system pacing using Lumenless leads

Clinical Study ID

NCT06049992
STYLE-LBBP 2023
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients referred for conduction system pacing

Exclusion

Exclusion Criteria:

  • Patients with a prosthetic (metal or biologic) tricuspid valve.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Pacemaker implantation with conduction system pacing using Stylet-driven leads
Phase:
Study Start date:
September 21, 2023
Estimated Completion Date:
September 22, 2025

Study 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.

Connect with a study center

  • Puerta de Hierro University Hospital

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • Fundación Jiménez Díaz University Hospital

    Madrid, 28040
    Spain

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.