Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 6:10 AM
Study NCT ID:
NCT03564860
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2018-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HBP Device EGM Data Collection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012804', 'term': 'Sick Sinus Syndrome'}, {'id': 'D054537', 'term': 'Atrioventricular Block'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D001146', 'term': 'Arrhythmia, Sinus'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2018-05-15', 'studyFirstSubmitQcDate': '2018-06-19', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amplitude of device electrogram', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Mean amplitude of device electrogram during His bundle pacing'}, {'measure': 'Duration of device electrogram', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Mean duration of device electrogram during His bundle pacing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sick Sinus Syndrome', 'AV Block', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'This is a single-arm, non-randomized, non-blinded study designed to collect device data in patients with permanent His bundle (HB) pacing lead and an existing Abbott permanent pacemaker, defibrillator, or cardiac resynchronization device. Prospective data collection includes surface electrocardiograms, intracardiac electrograms, and pacing parameters, recorded during a patient visit. Additional retrospective data collection includes procedural data during the HB pacing lead and device implant.\n\nUp to 200 subjects will participate in this clinical investigation. The clinical investigation will be conducted at up to 8 centers worldwide.\n\nThe total duration of the clinical investigation is expected to be 1 year, including enrollment and data collection from all subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The intended population for this clinical investigation consists of patients over the age of 18 years who have been previously implanted with a permanent His Bundle pacing lead and an Abbott pacemaker, defibrillator, or cardiac resynchronization therapy device.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has previously implanted with Abbott device and any pacing lead at HB\n* Age ≥ 18 years\n* Ability to provide informed consent for study participation\n* Willing to comply with study evaluation requirements\n\nExclusion Criteria:\n\n* Suspected pacing system failure\n* Lead impedance out of range\n* Ventricular sensing amplitude lower than 0.5 mV'}, 'identificationModule': {'nctId': 'NCT03564860', 'briefTitle': 'HBP Device EGM Data Collection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'His Bundle Pacing Device Electrogram Data Collection', 'orgStudyIdInfo': {'id': 'ABT-CIP-10234'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HBP device data collection group', 'description': 'Device electrograms and 12-lead ECG will be collected from patients over the age of 18 years who have been previously implanted with a permanent His Bundle pacing lead and an Abbott pacemaker, defibrillator, or cardiac resynchronization therapy device during a standard-of-care device follow-up visit.', 'interventionNames': ['Procedure: Device data collection']}], 'interventions': [{'name': 'Device data collection', 'type': 'PROCEDURE', 'description': 'Collection of device electrograms and 12-lead ECG during a device follow-up visit', 'armGroupLabels': ['HBP device data collection group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': '*Heart Center Research, LLC.', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '18840', 'city': 'Sayre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Donald Guthrie Foundation for Education & Research', 'geoPoint': {'lat': 41.97896, 'lon': -76.5155}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Health System', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}