Clinical trial NCT06049992: STylet-driven vs. LumenlEss Lead in Left-Bundle-Branch Pacing
Official title: Stylet-driven vs. Lumenless Lead in Left-Bundle-Branch Pacing Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Left Bundle-Branch Pacing
Keywords: Left bundle-branch pacing
Conduction system pacing
Leadless
Stylet-driven pacing leads
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
Collaborators: name: Spanish Society of Cardiology
First posted: 2023-09-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Proportion of patients in which left-bundle branch pacing is achieved at implantation
timeFrame: Baseline (During implantation)
measure: Proportion of patients with left-bundle branch pacing criteria at 24 hours
timeFrame: At 24 hours (before discharge)
Secondary outcomes:
measure: Procedural complications
timeFrame: At 24 hours
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Puerta de Hierro University Hospital
state: Madrid
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz University Hospital
Study officials:
affiliation: Puerta de Hierro University Hospital
name: Alvaro Lorente-Ros, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Puerta de Hierro University Hospital
name: Victor Castro-Urda, MD
role: STUDY_DIRECTOR
References:
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citation: De Pooter J, Wauters A, Van Heuverswyn F, Le Polain de Waroux JB. A Guide to Left Bundle Branch Area Pacing Using Stylet-Driven Pacing Leads. Front Cardiovasc Med. 2022 Feb 21;9:844152. doi: 10.3389/fcvm.2022.844152. eCollection 2022.
citation: Braunstein ED, Kagan RD, Olshan DS, Gabriels JK, Thomas G, Ip JE, Markowitz SM, Lerman BB, Liu CF, Cheung JW. Initial experience with stylet-driven versus lumenless lead delivery systems for left bundle branch area pacing. J Cardiovasc Electrophysiol. 2023 Mar;34(3):710-717. doi: 10.1111/jce.15789. Epub 2022 Dec 30.
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