Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-02-27 @ 4:08 PM
Study NCT ID:
NCT06535659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-02
First Post:
2024-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VitaFlow LIBERTY Europe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2032-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2024-07-21', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite rate of all-cause mortality and stroke with disability', 'timeFrame': '12 months post procedure', 'description': 'Composite rate of all-cause mortality and stroke with disability'}], 'secondaryOutcomes': [{'measure': 'Safety outcomes defined by VARC3', 'timeFrame': '30 days, 12 months, and 2-5 years post procedure', 'description': 'Rate of all-cause mortality, myocardial infarction, stroke, implanted related new and/or worsen conduction disturbances and arrhythmias, new permanent pacemaker implantation, procedure-related or valve-related hospitalization defined by VARC 3.'}, {'measure': 'Safety outcomes defined by VARC3', 'timeFrame': '30 days and 12 months post procedure', 'description': 'Rate of type 2-4 bleeding, major vascular and access-related complications, acute kidney injury (stage 2-4) defined by VARC 3'}, {'measure': 'Safety outcomes defined by VARC3', 'timeFrame': 'acute procedure (within 24 hours)', 'description': 'Rate of other acute procedural and technical valve related complications: conversion to surgery; unplanned use of mechanical circulatory support; implantation of multiple (\\>1) transcatheter valves during the index hospitalization; valve mal-position'}, {'measure': 'Device success', 'timeFrame': '30 days post implantation', 'description': 'Device success defined by VARC 3'}, {'measure': 'Device early safety', 'timeFrame': '30 days post implantation', 'description': 'Device early safety defined by VARC 3'}, {'measure': 'Bioprosthesis haemodynamic function', 'timeFrame': 'Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation', 'description': 'Bioprosthesis haemodynamic function (assessed by echocardiography) including effective orifice area (cm2).'}, {'measure': 'Bioprosthesis haemodynamic function', 'timeFrame': 'Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation', 'description': 'Bioprosthesis haemodynamic function (assessed by echocardiography) including mean transvalvular gradient (mmHg).'}, {'measure': 'Bioprosthesis haemodynamic function', 'timeFrame': 'Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation', 'description': 'Bioprosthesis haemodynamic function (assessed by echocardiography) including aortic regurgitation (paravalvular, central and total).'}, {'measure': 'Bioprosthetic valve dysfunction', 'timeFrame': '12 months and 2-5 years post procedure', 'description': 'Moderate or severe haemodynamic valve deterioration defined by VARC3'}, {'measure': 'Bioprosthetic valve dysfunction', 'timeFrame': '12 months and 2-5 years post procedure', 'description': 'Bioprosthetic valve failure defined by VARC3'}, {'measure': 'Bioprosthetic valve dysfunction', 'timeFrame': '12 months and 2-5 years post procedure', 'description': 'Clinically significant valve thrombosis defined by VARC3'}, {'measure': 'NYHA Classification', 'timeFrame': 'From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure', 'description': 'Changes in cardiac function at discharge, 30 days and 12 months and 2-5 years post implantation according to the NYHA Classification Scheme compared to baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcatheter aortic valve replacement'], 'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-arm, multi-center, observational, post-market registry to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the routine practice for the treatment of severe aortic valve stenosis. The primary endpoint is the composite rate of all-cause mortality and stroke with disability at 12 months.\n\nPatients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with symptomatic, severe calcified aortic stenosis who are at high surgical risk.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects of age≥ 18 years\n2. Subjects with severe, symptomatic, calcific aortic stenosis who are considered at high risk for surgical aortic valve replacement (AVR).\n3. Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow up requirements.\n\nExclusion Criteria:\n\n1. Pre-existing mechanical heart valve in aortic position\n2. A known hypersensitivity or contraindication to all anticoagulation /antiplatelet regimens (or inability to be anticoagulated for the index procedure), to nickel or titanium, to nitinol, to dairy products, to polyethylene terephthalate (PET) or contrast media\n3. Ongoing sepsis, including active endocarditis\n4. Anatomically not suitable for the VitaFlow Liberty TAV system\n5. LVEF\\<20%\n6. Estimated life expectancy of less than 12 months\n7. Any medical, social or psychological condition that in the opinion of the Heart Team precludes the subject from receiving transcatheter aortic valve replacement\n8. Currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed\n9. Inability to comply with the clinical investigation follow-up or other clinical investigation requirements\n10. Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)'}, 'identificationModule': {'nctId': 'NCT06535659', 'briefTitle': 'VitaFlow LIBERTY Europe', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai MicroPort CardioFlow Medtech Co., Ltd.'}, 'officialTitle': 'VitaFlow Liberty™ Transcatheter Aortic Valve System Post-market Clinical Follow-up Study', 'orgStudyIdInfo': {'id': 'VitaFlow EU-2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single arm clinical investigation', 'interventionNames': ['Device: VitaFlow Liberty™ Transcatheter Aortic Valve System']}], 'interventions': [{'name': 'VitaFlow Liberty™ Transcatheter Aortic Valve System', 'type': 'DEVICE', 'description': 'Transcatheter Aortic Valve Replacement with VitaFlow Liberty™ Transcatheter Aortic Valve System.\n\nPatients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.', 'armGroupLabels': ['Single arm clinical investigation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Galway', 'country': 'Ireland', 'contacts': [{'name': 'Darren Mylotte, MD', 'role': 'CONTACT'}], 'facility': 'Galway University Hospital', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}], 'centralContacts': [{'name': 'Luying Yan', 'role': 'CONTACT', 'email': 'lyyan@microport.com', 'phone': '86-010-66513642'}, {'name': 'Zhujun Cai, PhD', 'role': 'CONTACT', 'email': 'zjcai@microport.com', 'phone': '86-021-38954600'}], 'overallOfficials': [{'name': 'Darren Mylotte, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Galway University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai MicroPort CardioFlow Medtech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}