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

December 24, 2023 updated by: Alvaro Lorente-Ros, Puerta de Hierro University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Fundacion Jimenez Diaz University Hospital
        • Contact:
          • Jose Manuel Rubio, MD
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Puerta de Hierro University Hospital
        • Contact:
          • Alvaro Lorente-Ros, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lumenless lead
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
Pacemaker implantation for conduction system pacing will be done using leads without internal lumen (Lumenless; Medtronic Selectsecure 3830, Minneapolis, USA).
Active Comparator: Stylet-driven lead
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
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural complications
Time Frame: 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)
At 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puerta de Hierro University Hospital

Collaborators

Spanish Society of Cardiology

Investigators

  • Principal Investigator: Alvaro Lorente-Ros, MD, Puerta de Hierro University Hospital
  • Study Director: Victor Castro-Urda, MD, Puerta de Hierro University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2023

Primary Completion (Estimated)

September 21, 2025

Study Completion (Estimated)

September 22, 2025

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 16, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 24, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STYLE-LBBP 2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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