STylet-driven vs. LumenlEss Lead in Left-Bundle-Branch Pacing (STYLE-LBBP)

Majadahonda Iron Gate University

Status: Enrolling

Conditions: Left Bundle-Branch Pacing

Treatments: Device: Pacemaker implantation with conduction system pacing using Lumenless leads; Device: Pacemaker implantation with conduction system pacing using Stylet-driven leads

Study type: Interventional

Funder types: Other

Identifiers

NCT06049992

STYLE-LBBP 2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Lumenless lead

Active Comparator group

Description:

Left bundle branch stimulation using leads without internal lumen (Lumenless; Medtronic Selectsecure 3830, Minneapolis, USA).

Treatment:

Device: Pacemaker implantation with conduction system pacing using Lumenless leads

Stylet-driven lead

Active Comparator group

Description:

Left bundle branch pacing 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).

Treatment:

Device: Pacemaker implantation with conduction system pacing using Stylet-driven leads