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

Not Applicable

Recruiting

• Conditions: Left Bundle-Branch Pacing
• Interventions: Device: Pacemaker implantation with conduction system pacing using Lumenless leads; Device: Pacemaker implantation with conduction system pacing using Stylet-driven leads

• Registration Number: NCT06049992
• Lead Sponsor: Puerta de Hierro University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2023-09-16
• Study Start: 2023-09-21
• Study First Posted: 2023-09-22
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-24
• Last Update Posted: 2023-12-29
• Primary Completion: 2025-09-21
• Study Completion: 2025-09-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumenless lead	Pacemaker implantation with conduction system pacing using Lumenless leads	Left bundle branch stimulation using leads without internal lumen (Lumenless; Medtronic Selectsecure 3830, Minneapolis, USA).
Stylet-driven lead	Pacemaker implantation with conduction system pacing using Stylet-driven leads	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).

Primary Outcome Measures

Name	Time	Method
Proportion of patients in which left-bundle branch pacing is achieved at implantation	Baseline (During implantation)	Defined as a paced (pseudo) right bundle branch block QRS morphology with terminal r/R' in lead V1 and any of the following: i) recording of a LBB potential during intrinsic rhythm (only in patients with normal ventricular activation), ii) transition from non-selective to selective LBBP or non-selective LBBP to LV myocardial capture during decreasing pacing output, iii) abrupt shortening of stimulus to R wave peak time in V6 ECG lead (V6RWPT) ≥10 ms during implantation, iv) V6RWPT \< 75ms or \< 80ms in patients with preexisting left bundle branch block or v) an interpeak interval (V1RWPT - V6RWPT) ≥ 33ms.
Proportion of patients with left-bundle branch pacing criteria at 24 hours	At 24 hours (before discharge)	Defined as a paced (pseudo) right bundle branch block QRS morphology with terminal r/R' in lead V1 and any of the following: i) recording of a LBB potential during intrinsic rhythm (only in patients with normal ventricular activation), ii) transition from non-selective to selective LBBP or non-selective LBBP to LV myocardial capture during decreasing pacing output, iii) abrupt shortening of stimulus to R wave peak time in V6 ECG lead (V6RWPT) ≥10 ms during implantation, iv) V6RWPT \< 75ms or \< 80ms in patients with preexisting left bundle branch block or v) an interpeak interval (V1RWPT - V6RWPT) ≥ 33ms.

Secondary Outcome Measures

Name	Time	Method
Procedural complications	At 24 hours	Number of patients with major and minor complications related to the procedure (death, perforation, cardiac tamponade, lead dislodgment, loss of capture or need for reintervention)

Trial Locations

Locations (2)

Puerta de Hierro University Hospital; 🇪🇸 Majadahonda, Madrid, Spain

Fundación Jiménez Díaz University Hospital; 🇪🇸 Madrid, Spain