Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT05893758
Status:
COMPLETED
Last Update Posted:
2024-08-30
First Post:
2023-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lifetech Cera™ PFO Occluder Post-Market Clinical Follow-Up
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-29', 'studyFirstSubmitDate': '2023-05-30', 'studyFirstSubmitQcDate': '2023-05-30', 'lastUpdatePostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of stroke/TIA, procedure/device-related death and serious procedure/device complications', 'timeFrame': 'from attempted procedure to 24 months post-implantation.', 'description': 'Serious procedure/device complications include device embolization, cardiac or vascular perforation, atrial fibrillation, device thrombosis, pulmonary embolism and deep vein thrombosis.'}], 'secondaryOutcomes': [{'measure': 'Successful closure of the PFO, confirmed by contrast Transcranial Doppler (cTCD), defined as with no, small or moderate residual shunt', 'timeFrame': 'at procedure, 6 months and 12 months post-implantation'}, {'measure': 'Incidence of device or procedure related Adverse Events (AEs)', 'timeFrame': 'from attempted procedure to 24 months post-implantation'}, {'measure': 'Incidence of device or procedure related Serious Adverse Events (SAEs)', 'timeFrame': 'from attempted procedure to 24 months post-implantation'}, {'measure': 'Incidence of Device Deficiencies (DD)', 'timeFrame': 'from attempted procedure to 24 months post-implantation'}, {'measure': 'Incidence of death', 'timeFrame': 'from attempted procedure to 24 months post-implantation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lifetech', 'Cera PFO', 'Occluder'], 'conditions': ['Patent Foramen Ovale', 'PFO']}, 'descriptionModule': {'briefSummary': 'The objective of this post-market registry is to assess the clinical use of the Lifetech Cera™ PFO Occluder in a real-world and on-label fashion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a confirmed diagnosis of Patent Foramen Ovale (PFO) which is associated with TIA or cryptogenic stroke, and implanted with the investigational device.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with a confirmed diagnosis of Patent Foramen Ovale (PFO);\n2. Associated with TIA or cryptogenic stroke;\n3. Patients was implanted with the investigational device as per IFU instructions;\n4. Patients or legally authorized representatives have signed Data Release Consent or equivalent documents.\n\nExclusion Criteria:\n\n1. Any contraindication mentioned in the corresponding IFU;\n2. Patients did not conduct any follow up visit after hospital discharge.'}, 'identificationModule': {'nctId': 'NCT05893758', 'briefTitle': 'Lifetech Cera™ PFO Occluder Post-Market Clinical Follow-Up', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lifetech Scientific (Shenzhen) Co., Ltd.'}, 'officialTitle': 'A Real-world Registry Assessing the Clinical Use of the Lifetech Cera™ PFO Occluder', 'orgStudyIdInfo': {'id': 'LT-TS-275-2023-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PFO subjects', 'description': 'Patients with a confirmed diagnosis of Patent Foramen Ovale (PFO) which is associated with TIA or cryptogenic stroke, and implanted with the investigational device.', 'interventionNames': ['Device: The Cera™ PFO Occluder']}], 'interventions': [{'name': 'The Cera™ PFO Occluder', 'type': 'DEVICE', 'description': 'The Cera™ PFO Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of Patent Foramen Ovale (PFO).', 'armGroupLabels': ['PFO subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Myszków', 'country': 'Poland', 'facility': 'Oddział Kardiologii, Pracownia Hemodynamiki, Oddział Intensywnego Nadzoru Kardiologicznego oraz Pracownia Elektrofizjologii w Szpitalu w Myszkowie G.V.M.Carint', 'geoPoint': {'lat': 50.5752, 'lon': 19.32461}}, {'city': 'Oświęcim', 'country': 'Poland', 'facility': 'Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii G.V.M.Carint-Oświęcim', 'geoPoint': {'lat': 50.03437, 'lon': 19.21037}}, {'city': 'Tychy', 'country': 'Poland', 'facility': 'Polsko-Amerykańskie Kliniki Serca, Centrum Sercowo- Naczyniowe w Tychach, Grupa American Heart of Poland', 'geoPoint': {'lat': 50.13717, 'lon': 18.96641}}, {'city': 'Ustroń', 'country': 'Poland', 'facility': 'Polsko-Amerykańskie Kliniki Serca I Oddział Kardiologii Inwazyjnej i Niewydolności Serca w Ustroniu, Grupa AHoP', 'geoPoint': {'lat': 49.72153, 'lon': 18.80198}}, {'city': 'Zakopane', 'country': 'Poland', 'facility': 'Szpital Powiatowy im. dr Tytusa Chałubińskiego w Zakopanem', 'geoPoint': {'lat': 49.29899, 'lon': 19.94885}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lifetech Scientific (Shenzhen) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}