Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-26 @ 4:07 PM
Study NCT ID:
NCT06049992
Status:
RECRUITING
Last Update Posted:
2023-12-29
First Post:
2023-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STylet-driven vs. LumenlEss Lead in Left-Bundle-Branch Pacing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-24', 'studyFirstSubmitDate': '2023-09-11', 'studyFirstSubmitQcDate': '2023-09-16', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients in which left-bundle branch pacing is achieved at implantation', 'timeFrame': 'Baseline (During implantation)', 'description': "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."}, {'measure': 'Proportion of patients with left-bundle branch pacing criteria at 24 hours', 'timeFrame': 'At 24 hours (before discharge)', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Procedural complications', 'timeFrame': 'At 24 hours', 'description': '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)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Left bundle-branch pacing', 'Conduction system pacing', 'Leadless', 'Stylet-driven pacing leads'], 'conditions': ['Left Bundle-Branch Pacing']}, 'referencesModule': {'references': [{'pmid': '34455430', 'type': 'BACKGROUND', 'citation': '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': '31322651', 'type': 'BACKGROUND', 'citation': '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': '33602393', 'type': 'BACKGROUND', 'citation': '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': '31865972', 'type': 'BACKGROUND', 'citation': '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': '34888508', 'type': 'BACKGROUND', 'citation': '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': '35265691', 'type': 'BACKGROUND', '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.'}, {'pmid': '36571159', 'type': 'BACKGROUND', '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.'}, {'pmid': '35842801', 'type': 'BACKGROUND', 'citation': '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': '31233818', 'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nEfficacy 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients referred for conduction system pacing\n\nExclusion Criteria:\n\n* Patients with a prosthetic (metal or biologic) tricuspid valve.'}, 'identificationModule': {'nctId': 'NCT06049992', 'acronym': 'STYLE-LBBP', 'briefTitle': 'STylet-driven vs. LumenlEss Lead in Left-Bundle-Branch Pacing', 'organization': {'class': 'OTHER', 'fullName': 'Puerta de Hierro University Hospital'}, 'officialTitle': 'Stylet-driven vs. Lumenless Lead in Left-Bundle-Branch Pacing Randomized Trial', 'orgStudyIdInfo': {'id': 'STYLE-LBBP 2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lumenless lead', 'description': 'Left bundle branch stimulation using leads without internal lumen (Lumenless; Medtronic Selectsecure 3830, Minneapolis, USA).', 'interventionNames': ['Device: Pacemaker implantation with conduction system pacing using Lumenless leads']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stylet-driven lead', 'description': '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).', 'interventionNames': ['Device: Pacemaker implantation with conduction system pacing using Stylet-driven leads']}], 'interventions': [{'name': 'Pacemaker implantation with conduction system pacing using Lumenless leads', 'type': 'DEVICE', 'description': 'Pacemaker implantation for conduction system pacing will be done using leads without internal lumen (Lumenless; Medtronic Selectsecure 3830, Minneapolis, USA).', 'armGroupLabels': ['Lumenless lead']}, {'name': 'Pacemaker implantation with conduction system pacing using Stylet-driven leads', 'type': 'DEVICE', 'description': '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)', 'armGroupLabels': ['Stylet-driven lead']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alvaro Lorente-Ros, MD', 'role': 'CONTACT'}], 'facility': 'Puerta de Hierro University Hospital', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '28040', 'city': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose Manuel Rubio, MD', 'role': 'CONTACT'}], 'facility': 'Fundación Jiménez Díaz University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Alvaro Lorente-Ros, MD', 'role': 'CONTACT', 'email': 'alvaro.lorente@salud.madrid.org', 'phone': '911916000'}], 'overallOfficials': [{'name': 'Alvaro Lorente-Ros, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Puerta de Hierro University Hospital'}, {'name': 'Victor Castro-Urda, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Puerta de Hierro University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Puerta de Hierro University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Spanish Society of Cardiology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Alvaro Lorente-Ros', 'investigatorAffiliation': 'Puerta de Hierro University Hospital'}}}}