Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-06 @ 1:28 PM
Study NCT ID:
NCT03248232
Status:
COMPLETED
Last Update Posted:
2018-10-02
First Post:
2017-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessments of Thrombus Formation in TAVI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'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': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-30', 'studyFirstSubmitDate': '2017-08-09', 'studyFirstSubmitQcDate': '2017-08-09', 'lastUpdatePostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in plasma microRNAs', 'timeFrame': 'pre-, day 2 after device implantation', 'description': 'To measure the expression of plasma microRNAs before and after TAVI by using qPCR.'}], 'primaryOutcomes': [{'measure': 'Changes in T-TAS parameters (AR-chip, PL-chip) during TAVI', 'timeFrame': 'pre-, day 2, day 7, 1 month after device implantation', 'description': 'To measure the thrombus formation area under the curve for AR-chip (AR10-AUC30), and PL-chip (PL24-AUC10) before and after TAVI.'}], 'secondaryOutcomes': [{'measure': 'Changes in shear stress analyzed by using CFD analysis of contrast-enhanced CT', 'timeFrame': 'pre-, day 7 after device implantation', 'description': 'To measure the shear stress of aortic valve and aorta before and after TAVI by using CFD analysis of contrast-enhanced computed tomography (CT).'}, {'measure': 'Changes in von Willebrand factor multimer decrease', 'timeFrame': 'pre-, day 2 after device implantation', 'description': 'To measure the von Willebrand factor multimer decrease by using electrophoresis'}, {'measure': 'Periprocedural complication, particularly, bleeding complication defined by VARC-2 criteria.', 'timeFrame': 'within 30 days after device implantation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcatheter aortic valve implantation'], 'conditions': ['Aortic Valve Stenosis', 'Heart Valve Diseases']}, 'referencesModule': {'references': [{'pmid': '30976651', 'type': 'DERIVED', 'citation': 'Ishii M, Kaikita K, Mitsuse T, Nakanishi N, Oimatsu Y, Yamashita T, Nagamatsu S, Tabata N, Fujisue K, Sueta D, Takashio S, Arima Y, Sakamoto K, Yamamoto E, Tsujita K. Reduction in thrombogenic activity and thrombocytopenia after transcatheter aortic valve implantation - The ATTRACTIVE-TTAS study. Int J Cardiol Heart Vasc. 2019 Mar 28;23:100346. doi: 10.1016/j.ijcha.2019.100346. eCollection 2019 Jun.'}]}, 'descriptionModule': {'briefSummary': 'Transcatheter aortic valve implantation (TAVI) is well established, and can improve clinical outcomes of patients with severe aortic valve stenosis (AS) who are inoperable or have high surgical risk. Although the rates of periprocedural bleeding events are lower in TAVI compared to those in surgical aortic valve replacement, those in TAVI still remains high. In addition, current guideline recommended the dual antiplatelet (DAPT), clopidogrel plus aspirin, for a 3- to 6-month period after TAVI, however no evidences supports this approach. The antithrombotic regimen in patients undergoing TAVI is needed to be established.\n\nTo establish the antithrombotic regimen in patients undergoing TAVI,\n\n1. the investigators assess the changes in platelet thrombus formation and white thrombus formation in patients undergoing TAVI measured by Total Thrombus Formation Analysis System (T-TAS).\n2. the investigators analyze plasma microRNAs, and shear stress by using computational fluid dynamics (CFD) to clarify the mechanistic factors regarding those changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with severe symptomatic aortic valve stenosis, undergoing transcatheter aortic valve implantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* twenty years and older\n* with the informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated)\n\nExclusion Criteria:\n\n* withdrawn the informed consent\n* patients with trans-apical approach\n* critical illness condition (severe infectious disease, cancer, severe bleeding disorder)\n* transition to the surgical AVR'}, 'identificationModule': {'nctId': 'NCT03248232', 'briefTitle': 'Assessments of Thrombus Formation in TAVI', 'organization': {'class': 'OTHER', 'fullName': 'Kumamoto University'}, 'officialTitle': 'AssessmenTs of ThRombogenicity for trAnsCatheter aorTIc valVE Implantation by Total Thrombus-formation Analysis System (ATTRACTIVE-TTAS)', 'orgStudyIdInfo': {'id': 'Ethics No. 1440'}}, 'contactsLocationsModule': {'locations': [{'zip': '860-8556', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Kumamoto University Hospital', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kumamoto University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Cardiovascular Medicine, Principal Investigator', 'investigatorFullName': 'Kenichi Tsujita, MD, PhD', 'investigatorAffiliation': 'Kumamoto University'}}}}