STylet-driven vs. LumenlEss Lead in Left-Bundle-Branch Pacing
NCT ID: NCT06049992
Last Updated: 2023-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2023-09-21
2025-09-22
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lumenless lead
Left bundle branch stimulation using leads without internal lumen (Lumenless; Medtronic Selectsecure 3830, Minneapolis, USA).
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).
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).
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)
Interventions
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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).
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)
Eligibility Criteria
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Inclusion Criteria
* Patients referred for conduction system pacing
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Spanish Society of Cardiology
OTHER
Puerta de Hierro University Hospital
OTHER
Responsible Party
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Alvaro Lorente-Ros
Principal investigator
Principal Investigators
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Alvaro Lorente-Ros, MD
Role: PRINCIPAL_INVESTIGATOR
Puerta de Hierro University Hospital
Victor Castro-Urda, MD
Role: STUDY_DIRECTOR
Puerta de Hierro University Hospital
Locations
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Puerta de Hierro University Hospital
Majadahonda, Madrid, Spain
Fundación Jiménez Díaz University Hospital
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Alvaro Lorente-Ros, MD
Role: primary
Jose Manuel Rubio, MD
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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STYLE-LBBP 2023
Identifier Type: -
Identifier Source: org_study_id