NCT06049992

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

September 21, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2025

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

September 11, 2023

Last Update Submit

December 24, 2023

Conditions

Left Bundle-Branch Pacing

Keywords

Left bundle-branch pacingConduction system pacingLeadlessStylet-driven pacing leads

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Procedural complications

    At 24 hours

Study Arms (2)

Lumenless lead

ACTIVE COMPARATOR

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

Stylet-driven lead

ACTIVE COMPARATOR

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

Interventions

Pacemaker implantation with conduction system pacing using Lumenless leadsDEVICE

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

Lumenless lead
Pacemaker implantation with conduction system pacing using Stylet-driven leadsDEVICE

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)

Stylet-driven lead

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Puerta de Hierro University Hospital

Majadahonda, Madrid, 28222, Spain

RECRUITING

Fundación Jiménez Díaz University Hospital

Madrid, 28040, Spain

NOT YET RECRUITING

Related Publications (9)

  • Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available.

    PMID: 34455430BACKGROUND

  • Hou X, Qian Z, Wang Y, Qiu Y, Chen X, Jiang H, Jiang Z, Wu H, Zhao Z, Zhou W, Zou J. Feasibility and cardiac synchrony of permanent left bundle branch pacing through the interventricular septum. Europace. 2019 Nov 1;21(11):1694-1702. doi: 10.1093/europace/euz188.

    PMID: 31322651BACKGROUND

  • Vijayaraman P, Ponnusamy S, Cano O, Sharma PS, Naperkowski A, Subsposh FA, Moskal P, Bednarek A, Dal Forno AR, Young W, Nanda S, Beer D, Herweg B, Jastrzebski M. Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: Results From the International LBBAP Collaborative Study Group. JACC Clin Electrophysiol. 2021 Feb;7(2):135-147. doi: 10.1016/j.jacep.2020.08.015. Epub 2020 Oct 28.

    PMID: 33602393BACKGROUND

  • Zhang S, Zhou X, Gold MR. Left Bundle Branch Pacing: JACC Review Topic of the Week. J Am Coll Cardiol. 2019 Dec 17;74(24):3039-3049. doi: 10.1016/j.jacc.2019.10.039. Epub 2019 Dec 9.

    PMID: 31865972BACKGROUND

  • Tan JL, Lee JZ, Terrigno V, Saracco B, Saxena S, Krathen J, Hunter K, Cha YM, Russo AM. Outcomes of Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: An Updated Systematic Review and Meta-analysis. CJC Open. 2021 Jun 16;3(10):1282-1293. doi: 10.1016/j.cjco.2021.05.019. eCollection 2021 Oct.

    PMID: 34888508BACKGROUND

  • 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.

    PMID: 35265691BACKGROUND

  • 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.

    PMID: 36571159BACKGROUND

  • Shimeno K, Tamura S, Hayashi Y, Abe Y, Naruko T, Fukuda D. Achievement rate and learning curve of left bundle branch capture in left bundle branch area pacing procedure performed to demonstrate output-dependent QRS transition. J Cardiovasc Electrophysiol. 2022 Oct;33(10):2183-2191. doi: 10.1111/jce.15627. Epub 2022 Jul 23.

    PMID: 35842801BACKGROUND

  • Huang W, Chen X, Su L, Wu S, Xia X, Vijayaraman P. A beginner's guide to permanent left bundle branch pacing. Heart Rhythm. 2019 Dec;16(12):1791-1796. doi: 10.1016/j.hrthm.2019.06.016. Epub 2019 Jun 22. No abstract available.

    PMID: 31233818BACKGROUND

Study Officials

  • Alvaro Lorente-Ros, MD

    Puerta de Hierro University Hospital

    PRINCIPAL INVESTIGATOR

  • Victor Castro-Urda, MD

    Puerta de Hierro University Hospital

    STUDY DIRECTOR

Central Study Contacts

Alvaro Lorente-Ros, MD

CONTACT

911916000alvaro.lorente@salud.madrid.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 22, 2023

Study Start

September 21, 2023

Primary Completion

September 21, 2025

Study Completion

September 22, 2025

Last Updated

December 29, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)