Aortic Valve Stenosis Clinical Trial
Official title:
Prospective, Single-arm Pivotal Study for the Treatment of Subjects With Severe Symptomatic Calcific Aortic Valve Stenosis Using Valvosoft® Non-Invasive Ultrasound Therapy (NIUT)
Verified date | January 2024 |
Source | Cardiawave SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | August 15, 2024 |
Est. primary completion date | August 17, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Subject suffering from severe symptomatic calcific aortic valve stenosis as defined by ESC/EACTS guidelines for the management of valvular heart disease 2021; and 2. Subject is not recommended by the local HEART Team for immediate TAVR/SAVR; or 3. Subject who refuses TAVR/SAVR, documented by local HEART Team (not allowed in France); and 4. Age =18 years; and 5. Subject willing to provide a written informed consent prior to participating in the study; and 6. Subject who can comply with the study follow-up or other study requirements; and 7. Subject is eligible for the Valvosoft procedure according to Clinical Review Committee (CRC). Exclusion Criteria: 1. Subject with severe aortic regurgitation; or 2. Subject with unstable arrhythmia not controlled by medical treatment; or 3. Subjects with implanted mechanical valve in any position or bio-prosthetic valve in aortic position; or 4. Subject has a chest deformity not allowing optimal placement of Valvosoft Applicator and visualization of the aortic valve; or 5. Cardiogenic shock or other hemodynamic instability; or 6. Left Ventricular Ejection Fraction =30%; or 7. Subject with mean AVAI <0,24 cm²/m2; or 8. History of heart transplant; or 9. Subject requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after Valvosoft procedure; or 10. Cardiac imaging evidence of vegetation; or 11. Acute myocardial infarction (MI) within one month prior to enrolment; or 12. Valve depth not suitable for NIUT (depth >125mm with respect to the Valvosoft imaging probe); or 13. Stroke or transient ischemic attack (TIA) =1 month prior to enrollment; or 14. Subject who is pregnant, or plan to become pregnant during the 12-months study follow-up period; or 15. Subject who is participating in another research study for which the primary endpoint has not been reached; or 16. Balloon aortic valvuloplasty (BAV) =3 months prior to enrollment; or 17. Current endocarditis; or 18. 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 19. Life expectancy < 6 months due to non-cardiac co-morbid conditions; or 20. Other medical, psychological, or social condition which, in the opinion of the investigator, precludes the subject from study participation; or 21. Subjects who do not have Social Security and who are under legal restraint; or 22. Subjects who cannot read or write or are mentally not or partially capable of giving informed consent. |
Country | Name | City | State |
---|---|---|---|
France | CHU Lille Insitut Coeur Poumon | Lille | |
France | Hopital Bichat Claude-Bernard | Paris | |
France | Hopital Europeen Georges Pompidou | Paris | |
France | CHU Reims Hopital Robert Debré | Reims | |
France | CHU Rouen Hopital Charles Nicole | Rouen | |
France | Clinique Pasteur | Toulouse | |
Germany | Kerckhoff-klinik | Bad Nauheim | |
Germany | Marienkrankenhaus | Hamburg | |
Netherlands | OLVG | Amsterdam | |
Netherlands | Amphia Hospital | Breda | |
Netherlands | Radboudumc | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Cardiawave SA | QbD Clinical |
France, Germany, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety endpoint | Rate of MACE < 25% | at 30 days post-procedure | |
Primary | Performance endpoint | Improvement in clinical status assessed by means of a decrease in NHYA functional class | at 30 days post-procedure | |
Secondary | Rate of MACE | Rate of major adverse and cerebral events | peri-procedureal, and at 3-, 6- and 12 months post procedure | |
Secondary | All cause mortality | All cause mortality | 30 days, 3-, 6- and 12-months post procedure | |
Secondary | Rate of Stroke | Rate of stroke (disabling and non-disabling; ischemic and hemorrhagic) | 30 days, 3-, 6- and 12-months post procedure; | |
Secondary | AVA change at 30 days | 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 | 30 days post procedure | |
Secondary | AVA change in severity | 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 | at 6- and 12 months | |
Secondary | NYHA improvement | Change in clinical status assessed by means of a decrease in NYHA functional class | 3-, 6- and 12-months | |
Secondary | Change in 6 minutes walk test | Change in 6-minutes' walk test | 30 days, 6- and 12 months | |
Secondary | Improvement of quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ) | Improvement of quality of life by means of KCCQ. KCCQ is a 23-item, self-administered questionnaire | 30 days, 6-, and 12-months | |
Secondary | Improvement of quality of life by EQ-5D | 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. | 30 days, 6-, and 12-months |
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