Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-27 @ 10:16 PM
Study NCT ID:
NCT04349995
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-01
First Post:
2020-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amplatzer PFO Occluder Post-marketing Surveillance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054092', 'term': 'Foramen Ovale, Patent'}], 'ancestors': [{'id': 'D006344', 'term': 'Heart Septal Defects, Atrial'}, {'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-05-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-30', 'studyFirstSubmitDate': '2020-04-14', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'device- or procedure related SAE rate', 'timeFrame': 'up to 30 Days', 'description': 'device- or procedure related serious adverse events (SAEs) through 30 days'}, {'measure': 'PE, DVT and ischemic stroke and atrial fibrillation rate', 'timeFrame': 'beyond 30 days through 3 years', 'description': 'rate of pulmonary embolism (PE), deep vein thrombosis (DVT), ischemic stroke and atrial fibrillation beyond 30 days through 3 years'}, {'measure': 'Effective PFO closure', 'timeFrame': 'At 1 year', 'description': 'Effective closure of the PFO at 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PFO - Patent Foramen Ovale']}, 'descriptionModule': {'briefSummary': 'The purpose of the Amplatzer PFO Occluder post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.', 'detailedDescription': 'Based on the Ministerial Ordinance on Good Post-marketing Study Practice for Medical Device, the Surveillance will register patients with patent foramen ovale (PFO) who have experienced a PFO-related cryptogenic cerebral infarction (including diagnosed paradoxical cerebral embolism) or transient ischemic attack (determined by positive head imaging such as DWI) in whom an Amplatzer PFO Occluder implant was attempted (Marketing Approval No. 30100BZX00024000, date May 28, 2019, hereinafter referred to as "PFO occluder").'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be considered registered upon insertion of the Amplatzer PFO Occluder delivery system into the body', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Refer to Amplatzer PFO occluder IFU\n\nExclusion Criteria:\n\n* Refer to Amplatzer PFO occluder IFU'}, 'identificationModule': {'nctId': 'NCT04349995', 'acronym': 'PFO PMS Jpn', 'briefTitle': 'Amplatzer PFO Occluder Post-marketing Surveillance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Amplatzer PFO Occluder Post-marketing Surveillance Study', 'orgStudyIdInfo': {'id': 'ABT-CIP-10278'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Amplatzer PFO Occluder', 'description': 'Percutaneous PFO Closure using Amplatzer PFO occluder', 'interventionNames': ['Device: Amplatzer PFO Occluder']}], 'interventions': [{'name': 'Amplatzer PFO Occluder', 'type': 'DEVICE', 'description': 'Percutaneous PFO closure using Amplatzer PFO Occluder', 'armGroupLabels': ['Amplatzer PFO Occluder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '108-6304', 'city': 'Mita', 'state': 'Minato', 'country': 'Japan', 'facility': 'Abbott Medical Japan LLC', 'geoPoint': {'lat': 35.64799, 'lon': 139.74024}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}