[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632969":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":36,"responsibleParty":89,"collaborators":91,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":10,"enrollmentInfo":105,"targetDuration":10,"studyType":108,"phases":10,"briefSummary":109,"conditions":110,"keywords":10,"overallStatus":116,"whyStopped":10,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Cardiawave SA","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"observational group",null,"patients suffering from severe AS, not recommended for immediate AVR by local HEART Team or refusing an AVR and are treated with Valvosoft",[13],"Device: Valvosoft Treatment",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Valvosoft Treatment","non-invasive ultrasound therapy for the treatment of severe symptomatic calcific AS",[9],[21],"NIUT",[23],{"name":24,"affiliation":25,"role":26},"Won-Keun Kim","University Hospital Schleswig-Holstein","PRINCIPAL_INVESTIGATOR",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Dirk Pauwels","CONTACT","+33 (0)1 55 26 82 19","dirk.pauwels@cardiawave.com",{"name":34,"role":30,"phone":31,"phoneExt":10,"email":35},"Clemence PUPIER","clemence.pupier@cardiawave.com",[37,48,53,61,71,79],{"facility":38,"status":10,"city":39,"state":10,"zip":10,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":10},"Hopital Bichat","Paris","France","FR",{"type":43,"coordinates":44},"Point",[45,46],2.3488,48.85341,{"lat":46,"lon":45},{"facility":49,"status":10,"city":39,"state":10,"zip":10,"country":40,"countryCode":41,"cosmosGeoPoint":50,"geoPoint":52,"contacts":10},"Hopital Europeen Georges Pompidou",{"type":43,"coordinates":51},[45,46],{"lat":46,"lon":45},{"facility":54,"status":10,"city":55,"state":10,"zip":10,"country":40,"countryCode":41,"cosmosGeoPoint":56,"geoPoint":60,"contacts":10},"CHU Rouen Hopital Charles Nicolle","Rouen",{"type":43,"coordinates":57},[58,59],1.09932,49.44313,{"lat":59,"lon":58},{"facility":62,"status":10,"city":63,"state":10,"zip":10,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":70,"contacts":10},"Marienkrankenhaus","Hamburg","Germany","DE",{"type":43,"coordinates":67},[68,69],9.99302,53.55073,{"lat":69,"lon":68},{"facility":72,"status":10,"city":73,"state":10,"zip":10,"country":64,"countryCode":65,"cosmosGeoPoint":74,"geoPoint":78,"contacts":10},"University Hospital Schleswig Holstein Campus Kiel","Kiel",{"type":43,"coordinates":75},[76,77],10.13489,54.32133,{"lat":77,"lon":76},{"facility":80,"status":10,"city":81,"state":10,"zip":10,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":88,"contacts":10},"RadboudUMC","Nijmegen","Netherlands","NL",{"type":43,"coordinates":85},[86,87],5.85278,51.8425,{"lat":87,"lon":86},{"type":90,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[92],{"name":93,"class":94},"T!Write","UNKNOWN","100632969","valvosoft-outcomes-registry-for-real-world-evidence-100632969",false,"NCT07520591","Valvosoft Outcomes Registry for Real-World Evidence","Prospective Post-Market Clinical Follow-Up Registry to Assess the Long-term Safety and Effectiveness for the Treatment of Severe Symptomatic Aortic Valve Stenosis Using Valvosoft Non-Invasive Ultrasound Therapy","VALOR-PMCF","Inclusion Criteria:\n\n1. Suffering from calcific sSAS according to the definition presented in the current and applicable Guidelines for the management of valvular heart disease.\n2. Not recommended by the local heart team for immediate TAVR\u002FSAVR, or refusing such an intervention.\n3. Willing to provide a written informed consent prior to participating in this Registry.\n4. Able to comply with the follow up schedule or other Study requirements.\n\nExclusion Criteria:\n\n1. Prosthetic aortic valve;\n2. Chest deformity preventing optimal contact between Patient's chest and Valvosoft Applicator;\n3. Thoracic injured skin, presence of scar(s) and\u002For burn(s) on thorax that may be in contact or close proximity with Valvosoft Applicator;\n4. Pregnant or breastfeeding Patient.","ALL","18 Years",{"count":106,"type":107},200,"ESTIMATED","OBSERVATIONAL","The VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the Valvosoft® non-invasive ultrasound therapy (NIUT) device in patients with severe symptomatic calcific aortic stenosis (sSAS).\n\nValvosoft® delivers focused, high-intensity, short-duration ultrasound pulses to the aortic valve via a trans-thoracic approach, inducing non-thermal mechanical softening of calcified valve tissue.\n\nThis registry will enroll up to 200 participants across approximately 20 clinical sites in Europe following CE marking. Participants will be followed from discharge through 12 months post-procedure to assess clinical outcomes, quality of life, echocardiographic parameters, and safety events in a real-world setting.",[111,112,113,114,115],"Aortic Valve Disease","Aortic Stenosis, Severe","Aortic Valve Calcification","Ultrasound Therapy","Heart Failure","NOT_YET_RECRUITING","2026-04-09",{"date":119,"type":120},"2026-04-14","ACTUAL",{"date":122,"type":107},"2026-05-30",{"date":124,"type":107},"2028-06-30",{"name":5,"class":6},6]