Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-02-04 @ 10:13 PM
Study NCT ID:
NCT06542133
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2024-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AVEIR Remote Care System Non-Significant Risk Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D001919', 'term': 'Bradycardia'}], 'ancestors': [{'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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2024-07-18', 'studyFirstSubmitQcDate': '2024-08-02', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful end-to-end transmission performance metrics', 'timeFrame': "The expected duration of each subject's participation is approximately 30 minutes for an in-clinic visit to complete two transmissions and thereafter an optional at-home transmission (expected duration 10-15 minutes)", 'description': 'Successful transmission performance metrics of the AVEIR Remote Care System in approximately 32 subjects who have received an Aveir LP implanted system as part of their standard of care.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cardiac Pacemaker', 'Cardiac Rhythm Disorder', 'Bradycardia']}, 'referencesModule': {'references': [{'pmid': '40694240', 'type': 'DERIVED', 'citation': 'Sundaram S, Chellappa N, Chaniary K, Lo M, Nair D, Banker R. Remote monitoring of leadless pacemakers using a novel conductive telemetry communication method. J Interv Card Electrophysiol. 2025 Jul 22. doi: 10.1007/s10840-025-02095-8. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the study is to understand the performance of the AVEIR Remote Care System in an initial patient cohort which will inform the ability to offer a remote follow-up solution to all patients implanted with Aveir LP devices.', 'detailedDescription': 'To collect acute performance data about the AVEIR Remote Care System in participants implanted with a compatible dual or single chamber Aveir Leadless Pacemaker System by participants completing remote transmissions with the system'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must provide written informed consent prior to any study-related procedure.\n* Subject is willing and has consented to study clinical procedure.\n* Subject is ≥ 18 years of age or age of legal consent, whichever age is greater\n* Subject has an active, appropriately functioning Aveir leadless pacemaker system\n* Subject is willing to use the device\n\nExclusion Criteria:\n\n* Subject is unable to read/write at a sufficient level to provide informed consent.\n* Subject is unable to make the decision to participate in a clinical investigation on their own or are unable to fully understand all aspects of the investigation that are relevant to the decision to participate.\n* Subject has presence of medical, social, or psychological conditions that, in the investigator's opinion, could confound the study, limit the subject's ability to participate in the clinical investigation ."}, 'identificationModule': {'nctId': 'NCT06542133', 'briefTitle': 'AVEIR Remote Care System Non-Significant Risk Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'AVEIR Remote Care System Data Collection Non-Significant Risk Study', 'orgStudyIdInfo': {'id': 'ABT-CIP-10527'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational, Single Arm, Non Randomized', 'description': 'Aveir leadless pacemaker system patients', 'interventionNames': ['Device: AVEIR remote care system']}], 'interventions': [{'name': 'AVEIR remote care system', 'type': 'DEVICE', 'description': 'In-clinic or an at-home system designed to support remote follow up in Aveir leadless pacemaker patients', 'armGroupLabels': ['Observational, Single Arm, Non Randomized']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arrhythmia Research Group', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Heart Hospital', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Premier Cardiology, Inc', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}