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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Left Bundle-Branch Pacing

Intervention / Treatment
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* Device: Pacemaker implantation with conduction system pacing using Lumenless leads
* Device: Pacemaker implantation with conduction system pacing using Stylet-driven leads


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Patients referred for conduction system pacing Exclusion Criteria: Patients with a prosthetic (metal or biologic) tricuspid valve.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lumenless lead<br>Left bundle branch stimulation using leads without internal lumen (Lumenless; Medtronic Selectsecure 3830, Minneapolis, USA). | Device: Pacemaker implantation with conduction system pacing using Lumenless leads<br>* Pacemaker implantation for conduction system pacing will be done using leads without internal lumen (Lumenless; Medtronic Selectsecure 3830, Minneapolis, USA).<br>|
| Active Comparator: Stylet-driven lead<br>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). | Device: Pacemaker implantation with conduction system pacing using Stylet-driven leads<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients in which left-bundle branch pacing is achieved at 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. | Baseline (During implantation) | 
| Proportion of patients with left-bundle branch pacing criteria at 24 hours | 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. | At 24 hours (before discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural complications | 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) | At 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left bundle-branch pacing, Conduction system pacing, Leadless, Stylet-driven pacing leads