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

NCT06049992 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-12-29

No results posted yet for this 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.

Conditions

  • Left Bundle-Branch Pacing

Interventions

DEVICE

Pacemaker implantation with conduction system pacing using Lumenless leads

Pacemaker implantation for conduction system pacing will be done using leads without internal lumen (Lumenless; Medtronic Selectsecure 3830, Minneapolis, USA).

DEVICE

Pacemaker implantation with conduction system pacing using Stylet-driven leads

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)

Sponsors & Collaborators

  • Spanish Society of Cardiology

    collaborator OTHER

  • Puerta de Hierro University Hospital

    lead OTHER

Principal Investigators

  • Alvaro Lorente-Ros, MD · Puerta de Hierro University Hospital

  • Victor Castro-Urda, MD · Puerta de Hierro University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-21
Primary Completion
2025-09-21
Completion
2025-09-22

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06049992 on ClinicalTrials.gov