Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-01-22 @ 2:15 PM
Study NCT ID:
NCT02536703
Status:
UNKNOWN
Last Update Posted:
2015-09-01
First Post:
2015-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population
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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-27', 'studyFirstSubmitDate': '2015-08-27', 'studyFirstSubmitQcDate': '2015-08-27', 'lastUpdatePostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined rate of death from any cause, myocardial infarction, and stroke', 'timeFrame': '30 days following procedure', 'description': 'Outcome measures will be defined as suggested by the Valvular Academic Research Consortium (VARC)'}], 'secondaryOutcomes': [{'measure': 'Number of participants with procedural complications', 'timeFrame': '30 days following procedure'}, {'measure': 'Functional status (NYHA-classification)', 'timeFrame': '6 months following procedure'}, {'measure': 'Echocardiographic prosthesis status', 'timeFrame': '6 months following procedure'}, {'measure': 'Quality of Life (SF-12)', 'timeFrame': '6 months following procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'To confirm the safety and efficacy of the Lotus™ Valve System in the Chinese population for Transcatheter Aortic Valve Implantation (TAVI) in symptomatic patients with severe aortic stenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with symptomatic severe aortic stenosis (echocardiographic criteria: AV effective orifice area (EOA) of \\< 1 cm2, mean AV gradient of \\> 40 mmHg, or AV peak systolic velocity of \\> 4.0 m/s; NYHA-class II or greater, angina pectoris, or syncope)\n2. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.\n3. The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.\n4. Patients are technical and anatomical eligible for interventions\n\nExclusion Criteria:\n\n1. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:\n\n Aspirin Heparin (HIT/HITTS) and bivalirudin Nitinol (titanium or nickel) Ticlopidine and clopidogrel Contrast media\n2. Subject refuses a blood transfusion.\n3. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.\n4. Native aortic annulus size \\< 20 mm or \\> 29 mm per the baseline diagnostic imaging.\n5. Life expectancy is less than one year'}, 'identificationModule': {'nctId': 'NCT02536703', 'acronym': 'LOTUS-CHINA', 'briefTitle': 'Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'LOTUS-CHINA: Safety and Efficacy of Lotus Valve For Transcatheter Aortic Valve Implantation In Patients With Severe Aortic Stenosis In Chinese Population', 'orgStudyIdInfo': {'id': 'SAHZJU CT005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lotus Valve System', 'description': 'Transcatheter Aortic Valve Implantation (TAVI) with Lotus Valve System', 'interventionNames': ['Device: Lotus Valve System']}], 'interventions': [{'name': 'Lotus Valve System', 'type': 'DEVICE', 'description': 'Lotus Valve System', 'armGroupLabels': ['Lotus Valve System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Xianbao Liu, MD', 'role': 'CONTACT', 'email': 'liuxb2009@hotmail.com', 'phone': '+86-13857173887'}], 'facility': '2nd Affiliated Hospital, School of Medicine at Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Xianbao Liu, MD', 'role': 'CONTACT', 'email': 'liuxb2009@hotmail.com', 'phone': '+86-13857173887'}, {'name': 'Jian-an Wang, MD,PhD', 'role': 'CONTACT', 'email': 'Wang_jian_an@tom.com', 'phone': '+86-13805786328'}], 'overallOfficials': [{'name': 'Jian-an Wang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital Zhejiang University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology', 'investigatorFullName': "Jian'an Wang,MD,PhD", 'investigatorAffiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}}}}