Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-05 @ 6:42 AM
Study NCT ID:
NCT01761357
Status:
COMPLETED
Last Update Posted:
2015-09-23
First Post:
2013-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Burden Comorbidities and Transcatheter Aortic Valve Implantation
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2013-01-03', 'studyFirstSubmitQcDate': '2013-01-03', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and one month after the valve implantation.', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and three months after the valve implantation.', 'timeFrame': 'three months'}, {'measure': 'Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and six months after the valve implantation.', 'timeFrame': 'six months'}, {'measure': 'Difference of the score of the Instrumental Activities of Daily Living scale called "IADL", between inclusion and one month after the valve implantation.', 'timeFrame': 'one month'}, {'measure': 'Difference of the score of the Instrumental Activities of Daily Living scale called "IADL", between inclusion and three months after the valve implantation.', 'timeFrame': 'three months'}, {'measure': 'Difference of the score of the Instrumental Activities of Daily Living scale called "IADL", between inclusion and six months after the valve implantation.', 'timeFrame': 'six months'}, {'measure': 'Difference of the score of the Geriatric Depression Scale (GDS), between inclusion and one month after the valve implantation.', 'timeFrame': 'one month'}, {'measure': 'Difference of the score of the Geriatric Depression Scale called "GDS", between inclusion and three months after the valve implantation', 'timeFrame': 'three months'}, {'measure': 'Difference of the score of the Geriatric Depression Scale scale called "GDS", between inclusion and six months after the valve implantation', 'timeFrame': 'six months'}, {'measure': 'Complications during the six months of follow up with all causes of mortality', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aortic valve stenosis', 'Quality of life', 'Burden co morbidities', 'Transcatheter aortic valve implantation', 'Geriatric assessment'], 'conditions': ['Symptomatic Severe Aortic Valve Stenosis in Older Patients']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine whether the burden of comorbidities measured by CIRS-G (Cumulative Illness Rate Scale) is associated with a non-amelioration of the health related quality of life measured by questionnaire called "SF-36", six months after a transcatheter aortic valve replacement in older patients. During the comprehensive geriatric assessment realized before the valve implantation, the following data are recorded and their impact of the health related quality of life will also be analysed: comorbidity, age, depression, functional status, the cognitive impairment and malnutrition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 75 years and older\n* Patients referred for a transcatheter aortic valve implantation\n* Patients who have a comprehensive geriatric assessment realized during the three months before the valve implantation\n* Patients who provide informed written consent\n\nExclusion Criteria:\n\n* Patients who refuse the study\n* Patients with a legal guardian'}, 'identificationModule': {'nctId': 'NCT01761357', 'acronym': 'TAVIQUAL', 'briefTitle': 'Burden Comorbidities and Transcatheter Aortic Valve Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Impact of Burden of Comorbidities on Health Related Quality of Life Six Months After Transcatheter Aortic Valve Implantation in Patients Aged 75 Years and Older.', 'orgStudyIdInfo': {'id': 'RC12_0387'}}, 'armsInterventionsModule': {'interventions': [{'name': 'answering to questionnaires of quality of live', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'Angers Universitary Hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes Universitary Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}