Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
Study NCT ID:
NCT05235568
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2022-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VALVOSOFT® Pivotal Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562942', 'term': 'Aortic Valve, Calcification of'}, {'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': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2022-01-20', 'studyFirstSubmitQcDate': '2022-02-01', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety endpoint', 'timeFrame': 'at 30 days post-procedure', 'description': 'Rate of MACE \\< 25%'}, {'measure': 'Performance endpoint', 'timeFrame': 'at 30 days post-procedure', 'description': 'Improvement in clinical status assessed by means of a decrease in NHYA functional class'}], 'secondaryOutcomes': [{'measure': 'Rate of MACE', 'timeFrame': 'peri-procedureal, and at 3-, 6- and 12 months post procedure', 'description': 'Rate of major adverse and cerebral events'}, {'measure': 'All cause mortality', 'timeFrame': '30 days, 3-, 6- and 12-months post procedure', 'description': 'All cause mortality'}, {'measure': 'Rate of Stroke', 'timeFrame': '30 days, 3-, 6- and 12-months post procedure;', 'description': 'Rate of stroke (disabling and non-disabling; ischemic and hemorrhagic)'}, {'measure': 'AVA change at 30 days', 'timeFrame': '30 days post procedure', 'description': 'Change of 10% in of aortic stenosis by means of aortic valve area (AVA) (assessed by the independent echocardiographic Central Core Laboratory) 30 days post procedure compared to baseline'}, {'measure': 'AVA change in severity', 'timeFrame': 'at 6- and 12 months', 'description': 'Change in severity of aortic stenosis by means of aortic valve area (AVA) (assessed by the independent echocardiographic Central Core Laboratory) at 6- and 12 months compared to baseline'}, {'measure': 'NYHA improvement', 'timeFrame': '3-, 6- and 12-months', 'description': 'Change in clinical status assessed by means of a decrease in NYHA functional class'}, {'measure': 'Change in 6 minutes walk test', 'timeFrame': '30 days, 6- and 12 months', 'description': "Change in 6-minutes' walk test"}, {'measure': 'Improvement of quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'timeFrame': '30 days, 6-, and 12-months', 'description': 'Improvement of quality of life by means of KCCQ. KCCQ is a 23-item, self-administered questionnaire'}, {'measure': 'Improvement of quality of life by EQ-5D', 'timeFrame': '30 days, 6-, and 12-months', 'description': 'Improvement of quality of life by means of EQ-5D. The EQ-5D descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aortic Valve Stenosis', 'Aortic Valve Calcification', 'Aortic Valve', 'Stenosis', 'Ultrasound', 'non invasive'], 'conditions': ['Aortic Valve Calcification', 'Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject suffering from severe symptomatic calcific aortic valve stenosis as defined by ESC/EACTS guidelines for the management of valvular heart disease 2021; and\n2. Subject is not recommended by the local HEART Team for immediate TAVR/SAVR; or\n3. Subject who refuses TAVR/SAVR, documented by local HEART Team (not allowed in France); and\n4. Age ≥18 years; and\n5. Subject willing to provide a written informed consent prior to participating in the study; and\n6. Subject who can comply with the study follow-up or other study requirements; and\n7. Subject is eligible for the Valvosoft procedure according to Clinical Review Committee (CRC).\n\nExclusion Criteria:\n\n1. Subject with severe aortic regurgitation; or\n2. Subject with unstable arrhythmia not controlled by medical treatment; or\n3. Subjects with implanted mechanical valve in any position or bio-prosthetic valve in aortic position; or\n4. Subject has a chest deformity not allowing optimal placement of Valvosoft Applicator and visualization of the aortic valve; or\n5. Cardiogenic shock or other hemodynamic instability; or\n6. Left Ventricular Ejection Fraction ≤30%; or\n7. Subject with mean AVAI \\<0,24 cm²/m2; or\n8. History of heart transplant; or\n9. Subject requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after Valvosoft procedure; or\n10. Cardiac imaging evidence of vegetation; or\n11. Acute myocardial infarction (MI) within one month prior to enrolment; or\n12. Valve depth not suitable for NIUT (depth \\>125mm with respect to the Valvosoft imaging probe); or\n13. Stroke or transient ischemic attack (TIA) ≤1 month prior to enrollment; or\n14. Subject who is pregnant, or plan to become pregnant during the 12-months study follow-up period; or\n15. Subject who is participating in another research study for which the primary endpoint has not been reached; or\n16. Balloon aortic valvuloplasty (BAV) ≤3 months prior to enrollment; or\n17. Current endocarditis; or\n18. Leukopenia (WBC \\<4000 cell/μL), anemia (Hgb \\<8 g/dL), thrombocytopenia (platelet count \\<15.000 cell/μL), or history of coagulopathy or hypercoagulable state; or\n19. Life expectancy \\< 6 months due to non-cardiac co-morbid conditions; or\n20. Other medical, psychological, or social condition which, in the opinion of the investigator, precludes the subject from study participation; or\n21. Subjects who do not have Social Security and who are under legal restraint; or\n22. Subjects who cannot read or write or are mentally not or partially capable of giving informed consent.'}, 'identificationModule': {'nctId': 'NCT05235568', 'briefTitle': 'VALVOSOFT® Pivotal Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardiawave SA'}, 'officialTitle': 'Prospective, Single-arm Pivotal Study for the Treatment of Subjects With Severe Symptomatic Calcific Aortic Valve Stenosis Using Valvosoft® Non-Invasive Ultrasound Therapy (NIUT)', 'orgStudyIdInfo': {'id': 'CW21-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Valvosoft', 'description': 'Treatment with VALVOSOFT device', 'interventionNames': ['Device: VALVOSFT intervention']}], 'interventions': [{'name': 'VALVOSFT intervention', 'type': 'DEVICE', 'description': 'Treatment of the calcific aorta valve by non-invasive ultrasound therapy', 'armGroupLabels': ['Valvosoft']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'CHU Lille Insitut Coeur Poumon', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hopital Bichat Claude-Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hopital Europeen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Reims', 'country': 'France', 'facility': 'CHU Reims Hopital Robert Debré', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU Rouen Hopital Charles Nicole', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '31076', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff-klinik', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Marienkrankenhaus', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '1091 AC', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'OLVG', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia Hospital', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '6525 AG', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Christian Spaulding, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HEGP, Paris, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiawave SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'QbD Clinical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}