Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-25 @ 7:22 PM
Study NCT ID:
NCT03779620
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2018-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Valvosoft First-In-Man Study in Severe Symptomatic Aortic Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D003251', 'term': 'Constriction, Pathologic'}], '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'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Ultrasound treatment of calcified aortic valve stenosis'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2018-11-12', 'studyFirstSubmitQcDate': '2018-12-17', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Rate of procedure related mortality at 30 days', 'timeFrame': '30 days post-procedure', 'description': 'Rate of procedure related mortality at 30 days'}, {'measure': 'Device performance to modify valve structure as measured by echocardiography', 'timeFrame': 'Immediately post-procedure', 'description': 'Ability to modify the Aortic Valve Area (mm2)'}, {'measure': 'Device performance to modify valve structure as measured by echocardiography', 'timeFrame': 'Immediately post-procedure', 'description': 'Ability to modify the Pressure Gradient (mmHg)'}], 'secondaryOutcomes': [{'measure': "All-cause mortality and major adverse events (MAE's)", 'timeFrame': 'Up to 24 months', 'description': "Rate of all-cause mortality and MAE's peri and postprocedure and at 1, 3, 6, 12 and 24 months post operatively."}, {'measure': 'Non-disabling stroke', 'timeFrame': 'Up to 24 months', 'description': 'Rate of stroke at 1,3,6, 12 and 24 months'}, {'measure': 'Improvement of clinical status', 'timeFrame': 'Up to 24 months', 'description': 'Improvement of New York Heart Association class (I-IV - stage of severity of heart failure - I=no symptoms, IV= symptoms at rest) at 1,3,6,12, and 24 months.'}, {'measure': 'Number of all Adverse Events (AEs)', 'timeFrame': 'Up to 24 months', 'description': "Rate of AE's reported at at 1, 3, 6, 12 and 24 months"}, {'measure': 'User handeling of Valvosoft', 'timeFrame': 'Immediately post-procedure', 'description': 'User handling (questionnaire for operator + procedure duration) immediately post-procedure'}, {'measure': 'Improvement of quality of life', 'timeFrame': 'upto 24 months', 'description': 'Improvement of quality of life by means of Kansas City Cardiomyopathy Questionnaire at 1, 3, 6, 12 and 24 months'}, {'measure': 'Long term maintenance of improvement of AVA and PG', 'timeFrame': 'upto 24 months', 'description': 'Long term maintenance of improvement of AVA and PG at 3, 6, 12 and 24 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['symptomatic', 'aortic valve', 'stenosis', 'ultrasound', 'non-invasive'], 'conditions': ['Aortic Valve Stenosis']}, 'referencesModule': {'references': [{'pmid': '37972628', 'type': 'RESULT', 'citation': 'Messas E, Ijsselmuiden A, Trifunovic-Zamaklar D, Cholley B, Puymirat E, Halim J, Karan R, van Gameren M, Terzic D, Milicevic V, Tanter M, Pernot M, Goudot G. Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study. Lancet. 2023 Dec 16;402(10419):2317-2325. doi: 10.1016/S0140-6736(23)01518-0. Epub 2023 Nov 14.'}, {'pmid': '33486971', 'type': 'DERIVED', 'citation': 'Messas E, IJsselmuiden A, Goudot G, Vlieger S, Zarka S, Puymirat E, Cholley B, Spaulding C, Hagege AA, Marijon E, Tanter M, Bertrand B, Remond MC, Penot R, Ren B, den Heijer P, Pernot M, Spaargaren R. Feasibility and Performance of Noninvasive Ultrasound Therapy in Patients With Severe Symptomatic Aortic Valve Stenosis: A First-in-Human Study. Circulation. 2021 Mar 2;143(9):968-970. doi: 10.1161/CIRCULATIONAHA.120.050672. Epub 2021 Jan 25. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-man', 'detailedDescription': "CARDIAWAVE has developed a new non-invasive, real-time image-guided, therapeutic approach to treat patients suffering from Calcified Aortic Stenosis. CARDIAWAVE's Valvosoft device is a new ultrasound therapy based on a disruptive technology involving delivering an extremely precise and focused ultrasound beam to perform a reparative effect on the aortic valve leaflets, softening the valve's tissues, restoring leaflet mobility, and therefore improving the overall clinical status related to the aortic valve stenosis. This is a FIM study"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects suffering from severe symptomatic aortic valve stenosis (including subjects with a bicuspid valve).\n2. Patient is not eligible for TAVR/SAVR .\n3. Age ≥18 years.\n4. Subjects who are willing to provide a written informed consent prior to participating in the study.\n5. Subjects who can comply with the study follow up or other study requirements.\n6. Subject eligible according to Clinical Review Committee\n\n \\-\n\nExclusion Criteria:\n\n1. Subjects with any electrical device implanted.\n2. Subjects with unstable arrhythmia not controlled by medical treatment.\n3. Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position.\n4. Subjects with complex congenital heart disease.\n5. Chest deformity.\n6. Cardiogenic shock.\n7. History of heart transplant.\n8. Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after treatment.\n9. Thrombus in heart.\n10. Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one month prior to enrolment\\*.\n11. Subjects who are pregnant or nursing.\n12. Subjects who are participating in another research study for which the primary endpoint has not been reached.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT03779620', 'briefTitle': 'Valvosoft First-In-Man Study in Severe Symptomatic Aortic Stenosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardiawave SA'}, 'officialTitle': 'Prospective, Controlled, Single-arm Clinical Investigation for the Treatment of Subjects With Severe Symptomatic Aortic Valve Stenosis Using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Man', 'orgStudyIdInfo': {'id': 'CW19-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound treatment', 'description': 'Ultrasound treatment of patients with symptomatic aortic valve stenosis who are not eligible for valve replacement', 'interventionNames': ['Device: Ultrasound treatment of Calcified aortic valve']}], 'interventions': [{'name': 'Ultrasound treatment of Calcified aortic valve', 'type': 'DEVICE', 'description': 'Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacement', 'armGroupLabels': ['Ultrasound treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '4818CK', 'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia Hospital', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}], 'overallOfficials': [{'name': 'Emmanuel Messas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HGEP Paris, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiawave SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}