Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-22 @ 12:38 PM
Study NCT ID:
NCT05401851
Status:
UNKNOWN
Last Update Posted:
2024-02-28
First Post:
2022-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bi-ventricular Epicardial Activation in Left Bundle Area Pacing: a Comparison Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-10-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2022-04-04', 'studyFirstSubmitQcDate': '2022-05-27', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epicardial map', 'timeFrame': '1 day', 'description': 'Activation patterns (visual inspection) on non-invasive 3D ECG mapping'}, {'measure': 'Epicardial map', 'timeFrame': '1 day', 'description': 'Activation time (ms) on non-invasive 3D ECG mapping'}], 'secondaryOutcomes': [{'measure': 'Echo parameters for resynchronization', 'timeFrame': '90 days', 'description': 'LVEF (%)'}, {'measure': 'Echo parameters for resynchronization', 'timeFrame': '90 days', 'description': 'intraventricular delay (ms)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Left bundle area pacing', 'Pacemaker', 'Wide QRS'], 'conditions': ['Bradyarrhythmia', 'Pacemaker Syndrome', 'Biventricular Cardiac Pacemaker Malfunction']}, 'descriptionModule': {'briefSummary': 'Study of the ventricular activation patterns during left bundle area pacing and compare it with baseline activation during normal sinus rhythm in patients with and without baseline bundle branch conduction disorder.', 'detailedDescription': 'Right ventricular (RV) pacing has long been the gold standard treatment for symptomatic brady arrhythmias. Right ventricular apical pacing has shown to cause electrical and mechanical desynchrony resulting in left ventricular (LV) dysfunction, and, in some cases, clinical heart failure together with other mechanical and arrhythmic complications. Hence, it was necessary to find a more physiologic method of pacing that ensures synchrony. His bundle pacing was first described in 2000, and is more recently adapted as a pacing method with less deleterious effects on the RV. However, lead dislodgement, high pacing thresholds, battery depletion, and difficulty identifying the exact location of His bundle were the most significant concerns related to this method. Subsequently, left bundle branch area pacing (LBB-AP), first described in 2017 by Huang et al, has emerged as safe alternative with excellent lead stability and capture threshold, and more ability to correct distal conduction disease as compared to His bundle pacing. Recent studies report promising mid-term outcome concerning left ventricular desynchrony. To the best of our knowledge, bi-ventricular activation was never studied in patients with LBB-AP.\n\nMultiple tools have been used to assess biventricular (BiV) synchrony specially with chronic resynchronization therapy (CRT) including echocardiography and 12 lead ECG. Eschalier et al. found that epicardial noninvasive ECG mapping, was better at predicting clinical CRT response than QRS duration or the presence of LBBB. Activation patterns and timings with RV apical pacing, native LBBB, and BiV pacing have been well studied using this tool. With LBBP, however, these activation parameters have not yet been described.\n\nThis study aims to evaluate bi-ventricular activation in patients equipped with LBB-AP using non-invasive 3D mapping system in patients with or without baseline ventricular conduction disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 30 patients with a functional LBB-AP pacemaker\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Previous cardiac surgery\n* Cardiomyopathy with documented ventricular scar\n* Patients with prior pacemaker'}, 'identificationModule': {'nctId': 'NCT05401851', 'acronym': 'LBBAP', 'briefTitle': 'Bi-ventricular Epicardial Activation in Left Bundle Area Pacing: a Comparison Study', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Bi-ventricular Epicardial Activation in Left Bundle Area Pacing: a Comparison Study', 'orgStudyIdInfo': {'id': 'EC-2022-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Body surface mapping', 'description': 'With the Insite Vest, activation of the epicardium will be performed.', 'interventionNames': ['Device: Left Bundel Area Pacing']}], 'interventions': [{'name': 'Left Bundel Area Pacing', 'type': 'DEVICE', 'description': 'RV Lead will be placed deep in the interventricular septum', 'armGroupLabels': ['Body surface mapping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Carlo de Asmundis, MD, PhD', 'role': 'CONTACT', 'email': 'HRMC@uzbrussel.be'}, {'name': 'Aurélie Dubois', 'role': 'CONTACT', 'email': 'aurelie.dubois@uzbrussel.be', 'phone': '+3224763254'}], 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Carlo de Asmundis, MD, PhD', 'role': 'CONTACT', 'email': 'HRMC@uzbrussel.be', 'phone': '+32024763704'}, {'name': 'Aurélie Dubois', 'role': 'CONTACT', 'email': 'aurelie.dubois@uzbrussel.be', 'phone': '+3224763254'}], 'overallOfficials': [{'name': 'Carlo De Asmundis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Brussels'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}