Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-01-12 @ 2:39 PM
Study NCT ID:
NCT02971020
Status:
COMPLETED
Last Update Posted:
2018-03-26
First Post:
2016-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-22', 'studyFirstSubmitDate': '2016-09-12', 'studyFirstSubmitQcDate': '2016-11-21', 'lastUpdatePostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montreal Cognitive Assessment', 'timeFrame': 'Three Months', 'description': 'Estimate the means and standard deviations of changes in selected cognitive measures between baseline (pre-TAVR or pre-SAVR) and 3 months post-TAVR or post-SAVR, identify baseline correlates of those changes, and characterize baseline cognitive function and cognitive history of patients who undergo TAVR or SAVR.'}, {'measure': 'Trail Making', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cardiovascular Disease', 'Aortic Valve Stenosis', 'Cognitive Assessments', 'Valve Surgery', 'Transcatheter Valve Replacement', 'Surgical Valve Replacement']}, 'descriptionModule': {'briefSummary': 'The investigators are conducting a pilot study to compare cognitive outcomes among Veterans with severe aortic valve stenosis who are scheduled to undergo either aortic valve replacement.', 'detailedDescription': 'The investigators are conducting a pilot study to compare cognitive outcomes in up to 60 Veterans with severe aortic valve stenosis who are scheduled to undergo either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) at the Minneapolis VA Health Care System. Participants will be administered a short battery of cognitive tests before and three months after TAVR or SAVR over/up to a two year study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '104 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe aortic stenosis (AVA: 1 cm2 and/or mean gradient =or \\> 40 mmHg and/or peak velocity \\> 4 m/s)\n* Scheduled to undergo either surgical or transcatheter aortic valve replacement at the Minneapolis VA Health Care System\n\nExclusion Criteria:\n\n* Severe cognitive impairment at baseline (i.e. unable to understand or follow-up study procedures)\n* Unable or unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT02971020', 'acronym': 'CAVIAR', 'briefTitle': 'Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Center for Veterans Research and Education'}, 'officialTitle': 'Proposal for Collection of Patient Data to Aid in Design of an Observational Study (i.e. Preparatory to Research) Evaluating Risk of Cognitive Impairment After Surgical and Transcatheter Valve Replacement.', 'orgStudyIdInfo': {'id': '4588-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Surgical Aortic Valve Replacement', 'description': 'Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).', 'interventionNames': ['Other: Observational/Cognitive Assessment']}, {'type': 'OTHER', 'label': 'Transcatheter Aortic Valve Replacement', 'description': 'Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).', 'interventionNames': ['Other: Observational/Cognitive Assessment']}], 'interventions': [{'name': 'Observational/Cognitive Assessment', 'type': 'OTHER', 'description': 'Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).', 'armGroupLabels': ['Surgical Aortic Valve Replacement', 'Transcatheter Aortic Valve Replacement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis VA Health Care System', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Santiago Garcia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minneapolis Veterans Affairs Medical Center'}, {'name': 'Howard Fink, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minneapolis Veterans Affairs Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minnesota Veterans Medical Research and Education Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Minneapolis Veterans Affairs Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Santiago Garcia', 'investigatorAffiliation': 'Minnesota Veterans Medical Research and Education Foundation'}}}}