Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-28 @ 11:47 AM
Study NCT ID:
NCT05474092
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2021-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aeson TAH System - Post-Market Clinical Follow-up Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 95}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-19', 'studyFirstSubmitDate': '2021-06-29', 'studyFirstSubmitQcDate': '2022-07-21', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival rate', 'timeFrame': '90 days post-implant', 'description': 'Proportion of patients surviving on the originally implanted Aeson device (superiority test \\> 64%)'}], 'secondaryOutcomes': [{'measure': 'Survival and total support duration before transplantation', 'timeFrame': '6, 12, 18 and 24-months post-implant', 'description': 'Survival post-implant'}, {'measure': 'Health status change before transplantation', 'timeFrame': '3, 6, 9, 12, 18 and 24-months post-implant', 'description': 'Measured by EuroQol EQ-5D-5L questionnaire, health-related quality of life consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses (EQ-5D-5L). The responses record five levels of severity (1:no problems; 2:slight problems; 3:moderate problems 4:severe problems; 5:extreme problems) within a particular EQ-5D dimension'}, {'measure': 'Functional status change before transplantation', 'timeFrame': '3, 6, 9, 12, 18 and 24-months post-implant', 'description': 'Measured by 6 minutes walking distance in meters'}, {'measure': 'Length of hospital stay and time at home before transplantation', 'timeFrame': '3, 6, 9, 12, 18 and 24-months post-implant', 'description': 'Measured with discharge timing, frequency and duration of rehospitalizations; time at home or rehabilitation site'}, {'measure': 'Frequency and Incidence of Serious Adverse events before transplantation', 'timeFrame': '3, 6, 9, 12, 18 and 24-months post-implant', 'description': 'As defined by INTERMACS'}, {'measure': 'Assess the effectiveness of device upgrades', 'timeFrame': 'Between 3 and 24 months post-implantation, when heart transplant occurred', 'description': 'Standard expertise of explanted device'}, {'measure': 'Confirm the safety profile of the device after transplantation', 'timeFrame': '30 days, 3 months, 6 months, 12 months post-transplantation', 'description': 'Survival after transplantation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Heart Failure', 'Total Artificial Heart', 'Bridge to Transplant'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The safety and performance of the Aeson TAH system have been demonstrated for the CE mark approval in December 2020. The purpose of this post-market clinical investigation is to confirm the safety, performance and effectiveness of the Aeson TAH system when used in routine care by surgeons.', 'detailedDescription': 'The Primary objective/endpoint is survival rate on the originally implanted Aeson device at 90 days post-implant (H1 \\> 64%).\n\nThe second objectives/endpoints are:\n\n1. Confirm the performance and safety profile of the device for patients implanted with the Aeson TAH system until being transplanted:\n\n * Survival at 6, 12, 18, and 24-months post-implant, and total support duration before transplantation;\n * Health status change as measured by NYHA classification, 6MWT and Quality of Life Questionnaire (EQ-5D-5L);\n * Renal and hepatic function as measured by biological parameters;\n * Hemocompatibility profile measured by biological parameters and incidence of hemocompatible-related adverse events;\n * Frequency and Incidence of Serious Adverse events.\n2. Assess the effectiveness of device upgrades\n3. Confirm the safety profile of the device for patients after being transplanted.\n\n * Survival at 30 days, 6 months, and 12 months post-transplant\n * Frequency and Incidence of Serious Adverse Event of special interest as graft reject, neurological events, major bleeding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients intended to receive Aeson TAH system as per commercial use', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is intended to receive an Aeson TAH system according to the IFU indications within standard medical practice\n* Patient has provided written informed consent using the Ethics Committee approved consent form\n\nNon-inclusion Criteria:\n\n* Vulnerable populations who could not voluntarily consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT05474092', 'briefTitle': 'Aeson TAH System - Post-Market Clinical Follow-up Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Carmat SA'}, 'officialTitle': 'Evaluation of the Aeson® Total Artificial Heart (TAH) System in a Post-Market Approval Setting', 'orgStudyIdInfo': {'id': 'CAR2021-PM'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Aeson Total Artificial Heart', 'type': 'DEVICE', 'description': 'Heart Replacement Therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Manuel Wilbring', 'role': 'CONTACT', 'email': 'Manuel.Wilbring@herzzentrum-dresden.com', 'phone': '+49 351 450 25141'}], 'facility': 'HZ Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'centralContacts': [{'name': 'Elisabeth Vacher', 'role': 'CONTACT', 'email': 'Elisabeth.Vacher@carmatsas.com', 'phone': '+33 6 34 92 86 84'}, {'name': 'Piet Jansen', 'role': 'CONTACT', 'email': 'piet.jansen@carmatsas.com', 'phone': '+33 6 46 06 07 12'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmat SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}