Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-26 @ 1:12 AM
Study NCT ID:
NCT04564534
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2019-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Pre-procedure Cognitive Status on Outcome at 3 Months After 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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples will be taken and centrifuged, and plasma will be aliquoted and frozen at -80°Celsius for analysis of growth differentiation factor (GDF) 15.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-23', 'studyFirstSubmitDate': '2019-06-20', 'studyFirstSubmitQcDate': '2020-09-21', 'lastUpdatePostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause death', 'timeFrame': 'through 30 days after the TAVI procedure', 'description': 'Safety outcome at 3 months as assessed by the VARC2 criteria: all-cause death'}, {'measure': 'Stroke', 'timeFrame': 'through 30 days after the TAVI procedure', 'description': 'Safety outcome at 30 days as assessed by the VARC2 criteria: stroke'}, {'measure': 'life-threatening bleed', 'timeFrame': 'through 30 days after the TAVI procedure', 'description': 'Safety outcome at 30 days as assessed by the VARC2 criteria: life-threatening bleed'}, {'measure': 'Combined VARC2 safety outcome', 'timeFrame': 'through 30 days after the TAVI procedure', 'description': 'Safety criteria (within 30 days of the procedure) include all-cause death; stroke; life-threatening bleed; renal insufficiency; coronary artery obstruction requiring intervention; major vascular complication; valve dysfunction.\n\nClinical Efficacy criteria (30 days to 3 months after the procedure) include: all-cause death; stroke; re-admission for valve-rela'}, {'measure': 'Combined VARC2 efficacy outcome', 'timeFrame': 'through 30 days after the TAVI procedure', 'description': 'Clinical Efficacy criteria (30 days to 3 months after the procedure) include: all-cause death; stroke; re-admission for valve-related symptoms or worsening heart failure; NYHA Class III or IV; valve-related dysfunction.'}], 'secondaryOutcomes': [{'measure': 'Time required for MoCA', 'timeFrame': 'At the time of MoCA completion', 'description': 'Length of time required to administer the MoCA test using a tablet'}, {'measure': 'Biological parameters pre-procedure', 'timeFrame': 'pre-procedure', 'description': 'Blood count; prothrombin; TCA; fibrinogen; INR; creatinine; CRP; BNP; TSH; HbA1c; troponin; albumin; GDF15.'}, {'measure': 'Relationship between MoCA score and each component of the VARC2', 'timeFrame': 'At 3 months after TAVI procedure', 'description': 'The relationship between the MoCA and each individual component of the VARC2 will be investigated in bivariable analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transcatheter aortic valve replacement', 'aortic stenosis', 'cognitive status'], 'conditions': ['Aortic Stenosis']}, 'descriptionModule': {'briefSummary': 'This study plans to investigate the relationship between cognitive status pre-procedure, and clinical outcomes at 3 months in patients undergoing transcatheter aortic valve implantation (TAVI).', 'detailedDescription': 'This study plans to investigate the relationship between cognitive status pre-procedure, as assessed using the Montreal Cognitive Assessment (MoCA) administered on a tablet, and clinical outcomes at 3 months as assessed by the VARC2 criteria, in patients undergoing transcatheter aortic valve implantation (TAVI)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with aortic stenosis and a confirmed indication for TAVI, scheduled to undergo TAVI and who perform their pre-TAVI work-up in our centre will be invited to participate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or over\n* Scheduled to undergo TAVI\n* Provide informed consent\n* Able to understand French\n\nExclusion Criteria:\n\n* subjects under legal guardianship or other legal protection\n* subjects with documented severe dementia\n* subjects with anticipated poor compliance\n* subjects unable to understand French sufficiently well to perform the MoCA test\n* pregnant women\n* subjects within the exclusion period of another study'}, 'identificationModule': {'nctId': 'NCT04564534', 'acronym': 'TAVI-Geriatrie', 'briefTitle': 'Impact of Pre-procedure Cognitive Status on Outcome at 3 Months After Transcatheter Aortic Valve Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Impact of Pre-procedure Cognitive Status on Outcome at 3 Months After Transcatheter Aortic Valve Implantation', 'orgStudyIdInfo': {'id': 'P/2019/417'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study cohort', 'description': 'Adult (\\>18 years) patients with aortic stenosis in whom TAVI is planned and who perform their pre-TAVI work-up in our centre will be invited to undergo cognitive assessment using the MoCA at the time of their hospitalization for pre-TAVI work-up.\n\nThe MoCA will be administered by trained professionals with MoCA certification.\n\nClinical outcomes, as assessed by the VARC2 criteria, will be collected for all patients at 3 months after the TAVI procedure.', 'interventionNames': ['Other: MoCA cognitive assessment']}], 'interventions': [{'name': 'MoCA cognitive assessment', 'type': 'OTHER', 'description': 'cognitive assessment using the validated MoCA test administered via an application on an iPad', 'armGroupLabels': ['Study cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'University Hospital Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'overallOfficials': [{'name': 'Francois Schiele, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Besancon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}