Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-26 @ 8:58 AM
Study NCT ID:
NCT06014866
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2023-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conduction System Pacing With INGEVITY+
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1383}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2023-08-22', 'studyFirstSubmitQcDate': '2023-08-22', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lead-Related Complication Free Rate', 'timeFrame': 'Implant through 90 days', 'description': 'Adverse events that require correction with an invasive intervention or resulted in significant loss of device functionality.'}, {'measure': 'Pacing Threshold', 'timeFrame': 'Implant through 90 days', 'description': 'Percent of INGEVITY+ leads with pacing capture threshold measurement of less than or equal to 2V.'}, {'measure': 'Sensed R-wave amplitude', 'timeFrame': 'Implant through 90 days', 'description': 'Percent of INGEVITY+ leads with an R-wave amplitude greater than 5mV.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Conduction system pacing', 'Cardiac physiologic pacing'], 'conditions': ['Bradycardia']}, 'referencesModule': {'references': [{'pmid': '39914662', 'type': 'RESULT', 'citation': 'Friedman DJ, Shadrin I, Goldbarg S, Trulock KM, Patel A, Loring Z, Coles SA, Gandhi G, Upadhyay GA, Wold N, Jones PW, Ruble SB, Weinstock J, Latanich CA. Performance of an active fixation stylet-driven lead in left bundle branch area pacing: Results from INSIGHT-LBBA. Heart Rhythm. 2025 Aug;22(8):2047-2054. doi: 10.1016/j.hrthm.2025.01.041. Epub 2025 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'The study is intended to evaluate the safety and effectiveness of the Boston Scientific INGEVITY+ cardiac pacing lead when implanted in the left bundle branch area (LBBA).', 'detailedDescription': 'INSIGHT is a prospectively defined analysis of INGEVITY+ leads that have been previously implanted in the LBBA for the purpose of anti-bradycardia pacing. The results will provide complication free rate (safety) and lead measurements (performance).\n\nData will be gathered by means of a retrospective, multi-center, US only observational chart review to obtain data on INGEVITY+ leads implanted in the LBBA. Additional data will be gathered from the pulse generator and from the LATITUDE remote monitoring system for pacing thresholds and R-wave amplitude. Consecutive implants will be collected from each site for evaluating the endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients implanted with an INGEVITY+ lead implanted in the LBBA to provide rate support for bradycardia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for Primary Analysis:\n\n* De novo anti-bradycardia pacing pacemaker implant.\n* INGEVITY+ lead implant attempt in the LBBA as documented in the medical record at least 90 days ago.\n* LBBAP implant attempt employed a Boston Scientific SSPC series sheath\n\nExclusion Criteria for Primary Analysis:\n\n-ICD and CRT-D devices'}, 'identificationModule': {'nctId': 'NCT06014866', 'acronym': 'INSIGHT-LBBA', 'briefTitle': 'Conduction System Pacing With INGEVITY+', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'ConductIoN System pacInG witH IngeviTy+ for the Left Bundle Branch Area', 'orgStudyIdInfo': {'id': 'Pro00113475'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LBBA INGEVITY+ Pacing', 'description': 'Patients indicated for anti-bradycardia pacing that have been implanted with an INGEVITY+ lead in the LBBA.', 'interventionNames': ['Device: Cardiac pacing']}], 'interventions': [{'name': 'Cardiac pacing', 'type': 'DEVICE', 'description': "Patient's previously implanted with the INGEVITY+ lead located in the LBBA", 'armGroupLabels': ['LBBA INGEVITY+ Pacing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34233', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarasota Memorial Health Care System', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46227', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Heart And Vascular Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '55805', 'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'facility': "Essentia Health - Saint Mary's Duluth Clinic", 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}, {'zip': '11355', 'city': 'Flushing', 'state': 'New York', 'country': 'United States', 'facility': 'NewYork-Presbyterian Queens', 'geoPoint': {'lat': 40.76538, 'lon': -73.81736}}, {'zip': '27708', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'TriHealth Bethesda North Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '77479', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Sugar Land Hospital', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}], 'overallOfficials': [{'name': 'Daniel Friedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}