Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-05 @ 5:21 PM
Study NCT ID:
NCT04787757
Status:
COMPLETED
Last Update Posted:
2025-08-17
First Post:
2021-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autonomous Robotics for Transcatheter Cardiac Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 401}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2021-02-26', 'studyFirstSubmitQcDate': '2021-03-04', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of key procedural elements that will benefit from the technological developments introduced by ARTERY by collecting intraprocedural images', 'timeFrame': 'Intraoperative period', 'description': 'Number of patients undergoing percutaneous cardiac procedures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mitral Valve Disease', 'Heart Valve Diseases', 'Structural Heart Abnormality']}, 'referencesModule': {'references': [{'pmid': '39797996', 'type': 'BACKGROUND', 'citation': 'Munafo R, Saitta S, Tondi D, Ingallina G, Denti P, Maisano F, Agricola E, Votta E. Automatic 4D mitral valve segmentation from transesophageal echocardiography: a semi-supervised learning approach. Med Biol Eng Comput. 2025 Jan 11. doi: 10.1007/s11517-024-03275-w. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Cardiovascular diseases represent the most common cause of death worldwide. Percutaneous approaches with intravascular catheters are pivotal, since they allow to treat patients with high perioperative risks. However, catheter-based treatments require steep learning curves and are characterized by poor ergonomics and exposure to damaging radiation. ARTERY will offer a radiation-free approach based on shared-autonomy robotic catheters, with increased user engagement and easy interaction. Intraprocedural three-dimensional echocardiography as well as computed tomography images obtained during usual clinical practice will provide artificial intelligence algorithms that will turn catheter navigation to a simple task. Optical and electromagnetic sensing techniques will ensure a superior view upon the cardiovascular anatomy and will guide the autonomous catheter upon the interventionist supervision, who will be able to take over control at any instant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Candidates to percutaneous cardiac defects repair', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients\n* patients admitted to hospital undergoing percutaneous cardiac procedure\n* patients able to give informed consent\n\nExclusion Criteria:\n\n* age \\<18 years\n* refuse to give informed consent'}, 'identificationModule': {'nctId': 'NCT04787757', 'acronym': 'ARTERY', 'briefTitle': 'Autonomous Robotics for Transcatheter Cardiac Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Università Vita-Salute San Raffaele'}, 'officialTitle': 'Autonomous Robotics for Transcatheter dEliveRy sYstems', 'orgStudyIdInfo': {'id': 'ARTERY/08/2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Percutaneous cardiac procedures', 'description': 'Patients undergoing percutaneous cardiac procedures', 'interventionNames': ['Procedure: Percutaneous cardiac procedure']}], 'interventions': [{'name': 'Percutaneous cardiac procedure', 'type': 'PROCEDURE', 'description': 'Collection and analysis of intraprocedural information to provide artificial intelligence algorithms', 'armGroupLabels': ['Percutaneous cardiac procedures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Università Vita-Salute San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università Vita-Salute San Raffaele', 'class': 'OTHER'}, 'collaborators': [{'name': 'Politecnico di Milano', 'class': 'OTHER'}, {'name': "Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna", 'class': 'OTHER'}, {'name': 'KU Leuven', 'class': 'OTHER'}, {'name': 'SwissVortex', 'class': 'UNKNOWN'}, {'name': 'Artiness SRL', 'class': 'INDUSTRY'}, {'name': 'FBGS', 'class': 'UNKNOWN'}, {'name': 'IRCCS Ospedale San Raffaele', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Associate Professor', 'investigatorFullName': 'Giovanni Landoni', 'investigatorAffiliation': 'Università Vita-Salute San Raffaele'}}}}