Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-02-21 @ 11:04 AM
Study NCT ID:
NCT02803294
Status:
RECRUITING
Last Update Posted:
2021-07-15
First Post:
2016-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D065467', 'term': 'Transcatheter Aortic Valve Replacement'}], 'ancestors': [{'id': 'D019918', 'term': 'Heart Valve Prosthesis Implantation'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-14', 'studyFirstSubmitDate': '2016-06-07', 'studyFirstSubmitQcDate': '2016-06-13', 'lastUpdatePostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death from any cause', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'stroke', 'timeFrame': '30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years'}, {'measure': 'death from cardiac causes', 'timeFrame': '30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years'}, {'measure': 'myocardial infarction', 'timeFrame': '30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years'}, {'measure': 'repeated hospitalization', 'timeFrame': '30days, 6months,1 year,2 years, 3 years, 4 years, 5 years， 10 years'}, {'measure': 'acute kidney injury', 'timeFrame': '30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years'}, {'measure': 'vascular complications', 'timeFrame': '30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years'}, {'measure': 'bleeding events', 'timeFrame': '30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years'}, {'measure': 'device success', 'timeFrame': '30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years', 'description': 'Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \\<20 mmHg or peak velocity \\< 3 m/s, and no moderate or severe paravalvular regurgitation)'}, {'measure': 'Functional Improvement from baseline per New York Heart Association functional classification', 'timeFrame': '30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years'}, {'measure': 'permanent pacemaker implantation', 'timeFrame': '30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years', 'description': 'number of patients who develop permanent third-degree or type 2(Mobitz) Secondary atrioventricular block after transcatheter aortic valve replacement and need permanent pacemaker implantation.'}, {'measure': 'transcatheter valve failure', 'timeFrame': '30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years', 'description': 'leaflet thrombosis formation, reduced leaflet motion or leaflet thickening of the prosthetic valve'}, {'measure': 'changes in ascending aorta diameter', 'timeFrame': '1 year,2 years, 3 years, 4 years, 5 years，10 years'}, {'measure': 'Death from all causes', 'timeFrame': '30 days, 6 months,1 year,2 years, 3 years, 4 years, 5 years，10 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Symptomatic Aortic Stenosis']}, 'referencesModule': {'references': [{'pmid': '39080364', 'type': 'DERIVED', 'citation': 'Fan J, Chen J, Zhu G, Xu Y, Ng S, Dai H, Zhou D, Yidilisi A, Qi X, Liu X, Wang J. Impact of repositioning on brain injury following transcatheter aortic valve replacement with a self-expanding valve. Sci Rep. 2024 Jul 30;14(1):17554. doi: 10.1038/s41598-024-67748-6.'}, {'pmid': '38816554', 'type': 'DERIVED', 'citation': 'Zhou Q, Wen J, Zhu Q, Fan J, Guan X, Chen X, He Y, Guo Y, Jiang J, Ding X, Pu Z, Huang Z, Li C, Zhang M, Liu X, Xu X, Wang J. Long-term prosthetic-associated subclinical thrombotic events evaluation by cardiac CTA after transcatheter aortic valve implantation: incidence and outcomes. Insights Imaging. 2024 May 30;15(1):125. doi: 10.1186/s13244-024-01681-0.'}, {'pmid': '35413789', 'type': 'DERIVED', 'citation': 'Hu P, Chen H, Wang LH, Jiang JB, Li JM, Tang MY, Guo YC, Zhu QF, Pu ZX, Lin XP, Ng S, Liu XB, Wang JA. Elevated N-terminal pro C-type natriuretic peptide is associated with mortality in patients undergoing transcatheter aortic valve replacement. BMC Cardiovasc Disord. 2022 Apr 12;22(1):164. doi: 10.1186/s12872-022-02615-8.'}, {'pmid': '33243378', 'type': 'DERIVED', 'citation': 'Fan J, Fang X, Liu C, Zhu G, Hou CR, Jiang J, Lin X, Wang L, He Y, Zhu Q, Ng S, Chen Z, Hu H, Liu X, Wang J, Leon MB. Brain Injury After Transcatheter Replacement of Bicuspid Versus Tricuspid Aortic Valves. J Am Coll Cardiol. 2020 Dec 1;76(22):2579-2590. doi: 10.1016/j.jacc.2020.09.605.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of transcatheter aortic valve replacement in Chinese population.', 'detailedDescription': 'Subjects enrolled are those who undergo physical exams and screening tests and were classified as a patient with symptomatic aortic stenosis or severe aortic regurgitation. They are then performed transcatheter aortic valve replacement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with symptomatic aortic stenosis/regurgitation\n* Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.\n* The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.\n* Patients are technical and anatomical eligible for interventions\n\nExclusion Criteria:\n\n* A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: Aspirin Heparin (HIT/HITTS) and bivalirudin Nitinol (titanium or nickel) Ticlopidine and clopidogrel Contrast media\n* Subject refuses a blood transfusion.\n* Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.\n* Life expectancy is less than one year'}, 'identificationModule': {'nctId': 'NCT02803294', 'acronym': 'TORCH', 'briefTitle': 'Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'THE TORCH TRIAL：Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population', 'orgStudyIdInfo': {'id': 'SAHZJU CT006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aortic Stenosis/regurgitation', 'description': 'Transcatheter aortic valve replacement', 'interventionNames': ['Procedure: transcatheter aortic valve replacement']}], 'interventions': [{'name': 'transcatheter aortic valve replacement', 'type': 'PROCEDURE', 'armGroupLabels': ['Aortic Stenosis/regurgitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hanzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianbao Liu, PHD', 'role': 'CONTACT', 'email': 'liuxb@zju.edu.cn'}], 'facility': 'The Second Affiliated Hospital, School of Medicine at Zhejiang University'}], '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 of 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, Second Affiliated Hospital, School of Medicine, Zhejiang University', 'investigatorFullName': "Jian'an Wang,MD,PhD", 'investigatorAffiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}}}}