Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT03453567
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-24
First Post:
2018-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Effectiveness and Safety of Aortic Valve Replacement in Routine Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2030-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2018-02-27', 'studyFirstSubmitQcDate': '2018-02-27', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause death', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular mortality', 'timeFrame': '5 years', 'description': 'A. Death due to proximate cardiac cause B. Death caused by noncoronary vascular condition C. All procedure-related/surgery-related death D. All valve-related death E. Sudden or unwitnessed death F. Death of unknown cause\n\nEither Discharge or 30-day, at the earliest time point\n\n1-,6-, and 12-months, and 3-,5-years'}, {'measure': 'Myocardial infarction', 'timeFrame': '5 years', 'description': 'Either Discharge or 30-day, at the earliest time point\n\n1-,6-, and 12-months, and 3-,5-years'}, {'measure': 'All stroke and transient ischemic attack', 'timeFrame': '5 years', 'description': 'Either Discharge or 30-day, at the earliest time point\n\n1-,6-, and 12-months, and 3-,5-years'}, {'measure': 'Bleeding', 'timeFrame': '5 years', 'description': 'Either Discharge or 30-day, at the earliest time point\n\n1-,6-, and 12-months, and 3-,5-years'}, {'measure': 'Access site complication', 'timeFrame': '5 years', 'description': 'Operation site complication Vascular access site and access-related complication\n\nEither Discharge or 30-day, at the earliest time point\n\n1-,6-, and 12-months, and 3-,5-years'}, {'measure': 'Acute kidney injury', 'timeFrame': '5 years', 'description': 'Either Discharge or 30-day, at the earliest time point\n\n1-,6-, and 12-months, and 3-,5-years'}, {'measure': 'Permanent pacemaker insertion', 'timeFrame': '5 years', 'description': 'Either Discharge or 30-day, at the earliest time point\n\n1-,6-, and 12-months, and 3-,5-years'}, {'measure': 'TAVR-related complication', 'timeFrame': '5 years', 'description': 'A. Conversion to open surgery B. Coronary obstruction C. Mitral valve apparatus damage or dysfunction D. Cardiac tamponade E. Endocarditis F. Valve thrombosis G. Valve malpositioning H. TAV-in-TAV deployment\n\nEither Discharge or 30-day, at the earliest time point\n\n1-,6-, and 12-months, and 3-,5-years'}, {'measure': 'Prosthetic valve dysfunction', 'timeFrame': '5 years', 'description': 'A. Prosthetic aortic valve stenosis B. Prosthesis-patient mismatch C. Prosthetic aortic valve regurgitation\n\nEither Discharge or 30-day, at the earliest time point\n\n1-,6-, and 12-months, and 3-,5-years'}, {'measure': 'Composite event', 'timeFrame': '5 years', 'description': 'A. Device success B. Early safety (30 days)\n\n* Death, stroke, life-threatening bleeding, acute kidney injury, coronary stenosis requiring intervention, significant vascular complication, valve dysfunction requiring intervention C. Clinical efficacy (30 days)\n* Death, stroke, deteriorating heart failure or valve function requiring hospitalization, NYHA III or IV dyspnea, valve dysfunction\n\nEither Discharge or 30-day, at the earliest time point\n\n1-,6-, and 12-months, and 3-,5-years'}, {'measure': 'Structural valve deterioration', 'timeFrame': '5 years', 'description': 'Either Discharge or 30-day, at the earliest time point\n\n1-,6-, and 12-months, and 3-,5-years'}, {'measure': 'NYHA class', 'timeFrame': '30 days and 1 year', 'description': 'New York Heart Association (NYHA) Functional Classification'}, {'measure': 'The change of valve area', 'timeFrame': '30 days and 1 year', 'description': 'Aortic valve area measured by echocardiography (mm2)'}, {'measure': 'New onset atrial fibrillation', 'timeFrame': '30 days and 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TAVR', 'SAVR', 'TAVI', 'Conventional AVR', 'Sutureless AVR'], 'conditions': ['Aortic Valve Disease', 'Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'This study evaluated effectiveness and safety of aortic valve replacement in real-world clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with aortic valve replacement', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19 and more\n* Patient with aortic valve replacement\n\nExclusion Criteria:\n\n* Combined with mitral stenosis requiring surgery or aorta stenosis\n* Acute bacterial endocarditis within 1 month of valve replacement'}, 'identificationModule': {'nctId': 'NCT03453567', 'acronym': 'IRIS AVR', 'briefTitle': 'Evaluation of Effectiveness and Safety of Aortic Valve Replacement in Routine Clinical Practice', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Evaluation of Effectiveness and Safety of Aortic Valve Replacement in Routine Clinical Practice; A Multicenter, Prospective Observational Study', 'orgStudyIdInfo': {'id': 'AMCCV2018-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TAVR', 'description': 'Transcatheter Aortic Valve Replacement', 'interventionNames': ['Procedure: Valve Replacement']}, {'label': 'Sutureless AVR', 'description': 'Sutureless Aortic Valve Replacement', 'interventionNames': ['Procedure: Valve Replacement']}, {'label': 'Conventional AVR', 'description': 'Conventional Aortic Valve Replacement', 'interventionNames': ['Procedure: Valve Replacement']}], 'interventions': [{'name': 'Valve Replacement', 'type': 'PROCEDURE', 'description': 'Aortic valve replacement', 'armGroupLabels': ['Conventional AVR', 'Sutureless AVR', 'TAVR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Sejong Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Yangsan', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'overallOfficials': [{'name': 'Suk-Jung Choo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seung-Jung Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Division of Cardiology', 'investigatorFullName': 'Seung-Jung Park', 'investigatorAffiliation': 'Asan Medical Center'}}}}