Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2025-12-29 @ 5:09 PM
Study NCT ID:
NCT05887700
Status:
RECRUITING
Last Update Posted:
2025-01-08
First Post:
2023-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006344', 'term': 'Heart Septal Defects, Atrial'}], 'ancestors': [{'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': 'ESTIMATED', 'count': 145}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2023-05-24', 'studyFirstSubmitQcDate': '2023-05-24', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedural success', 'timeFrame': '6 months post-implantation', 'description': 'Procedural success is defined as a composite of:\n\n1. Absence of stroke/TIA, device embolization, cardiac or vascular perforation or device/procedure related death, assessed at 6 months post-implantation.\n2. Successful closure of the defects, with no, trivial or small residual shunt confirmed by Doppler echocardiography at 6 months post-implantation.'}], 'secondaryOutcomes': [{'measure': 'Incidence of moderate or large 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', 'Atrial Septal Defect', 'ASD', 'CeraFlex', 'ASD Closure System'], 'conditions': ['Atrial Septal Defect']}, 'descriptionModule': {'briefSummary': 'The objective of this post-market registry is to assess the clinical use of the Lifetech CeraFlex™ Closure System in a real-world and on-label fashion.', 'detailedDescription': 'The study intends to collect data from patients who have implanted with the device between 2019 and 2022. The data collection process is expected to complete by end of 2024. Final report shall be available in 2025.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device as per IFU instructions.\n2. Patients or legally authorized representatives have signed Data Release Consent or equivalent documents.\n\nExclusion Criteria:\n\nPatients did not conduct any follow up visit after hospital discharge.'}, 'identificationModule': {'nctId': 'NCT05887700', 'briefTitle': 'Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lifetech Scientific (Shenzhen) Co., Ltd.'}, 'officialTitle': 'A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System', 'orgStudyIdInfo': {'id': 'LT-TS-271-2023-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ASD subjects', 'description': 'Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device.', 'interventionNames': ['Device: CeraFlex™ Atrial Septal Defect (ASD) Closure System']}], 'interventions': [{'name': 'CeraFlex™ Atrial Septal Defect (ASD) Closure System', 'type': 'DEVICE', 'description': 'The CeraFlex™ ASD Occluder have two types of occluders, CeraFlex™ ASD Occluder and CeraFlex™ Multi-fenestrated (Cribriform) ASD Occluder. The CeraFlex™ ASD Occluder is percutaneous, transcatheter closure devices for the non-surgical closure of atrial septal defects.', 'armGroupLabels': ['ASD subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Curitiba', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Leo Solarewicz', 'role': 'CONTACT'}], 'facility': 'Hospital Pequeno Príncipe', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'city': 'Fortaleza', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'José Filho', 'role': 'CONTACT'}], 'facility': 'Universidade Federal do Ceará', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'city': 'Porto Alegre', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Carlo Pilla', 'role': 'CONTACT'}], 'facility': 'Santa Casa de Misericórdia de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'São Paulo', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Carlos Pedra', 'role': 'CONTACT'}], 'facility': 'HCOR - Associação Beneficente Síria', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Salvador Cristóvão', 'role': 'CONTACT'}], 'facility': 'Hospital Beneficência Portuguesa', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Kallithea', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Spyros Rammos', 'role': 'CONTACT'}, {'name': 'Ioannis Papagiannis', 'role': 'CONTACT'}], 'facility': 'Onassis Cardiac Surgery Center', 'geoPoint': {'lat': 37.95, 'lon': 23.7}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mario Carminati', 'role': 'CONTACT'}], 'facility': 'IRCCS Policlinico San Donato', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Rae Gong, PM', 'role': 'CONTACT', 'email': 'gongrui@lifetechmed.com', 'phone': '(86-755)-86026250-6957'}, {'name': 'KaDirr Shemsi, APM', 'role': 'CONTACT', 'email': 'KaDirr@lifetechmed.com', 'phone': '+86-176-2130-9203'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lifetech Scientific (Shenzhen) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}