Ignite Creation Date:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT04944667
Status:
COMPLETED
Last Update Posted:
2022-03-22
First Post:
2021-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement
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': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-06-21', 'lastUpdatePostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TAVR procedure planning (prosthesis size, implant technique requirements, potential risks)', 'timeFrame': 'Baseline', 'description': 'Does the TAVR procedure planning change after VR?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Stenosis, Severe']}, 'descriptionModule': {'briefSummary': 'This study sought to evaluate the impact of Virtual Reality (VR) tools in procedural planning of transcatheter aortic valve replacement (TAVR).', 'detailedDescription': 'A prospective study involving 11 patients referred for TAVR was conducted. A multidetector computed tomography (MDCT) was used to acquire and segment the anatomy of the access route and landing zone. From the information obtained with the MDCT in DICOM format, the investigators built a virtual platform (VisuaMed, Teacher Team. Valencia. Spain) that contains all the clinical information of the patients and a virtualized model of their anatomy. Wearing VR devices, the professional was able to "walk inside " the anatomy in an interactive and immersive way. Decisions after the evaluation of routine clinical images were compared with those after experience with VR models and intraprocedural findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe aortic stenosis considered for TAVR procedure at a single Institution\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04944667', 'briefTitle': 'Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Centro Medico Teknon'}, 'officialTitle': 'Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement (TAVR)', 'orgStudyIdInfo': {'id': 'Cardiac Surgery CentroMT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'TAVR standard', 'description': 'TAVR planning evaluated without VR and TAVR planning after VR analysis', 'interventionNames': ['Diagnostic Test: TAVR planning']}], 'interventions': [{'name': 'TAVR planning', 'type': 'DIAGNOSTIC_TEST', 'description': 'TAVR planning without VR vs after VR', 'armGroupLabels': ['TAVR standard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08022', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'CentroMT (Centro Médico Teknon)', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Medico Teknon', 'class': 'OTHER'}, 'collaborators': [{'name': 'Techer Team SL. Valencia. Spain', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Md,PhD', 'investigatorFullName': 'Eduard Permanyer', 'investigatorAffiliation': 'Centro Medico Teknon'}}}}