Aortic Valve Calcification, Aortic Valve Stenosis
Conditions
Keywords
Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve, Stenosis, Ultrasound, non invasive
Brief summary
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
Interventions
DEVICEVALVOSFT intervention
Treatment of the calcific aorta valve by non-invasive ultrasound therapy
Sponsors
QbD Clinical
Cardiawave SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety endpoint | at 30 days post-procedure | Rate of MACE \< 25% |
| Performance endpoint | at 30 days post-procedure | Improvement in clinical status assessed by means of a decrease in NHYA functional class |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Stroke | 30 days, 3-, 6- and 12-months post procedure; | Rate of stroke (disabling and non-disabling; ischemic and hemorrhagic) |
| AVA change at 30 days | 30 days post procedure | 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 |
| AVA change in severity | at 6- and 12 months | 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 |
| Rate of MACE | peri-procedureal, and at 3-, 6- and 12 months post procedure | Rate of major adverse and cerebral events |
| Change in 6 minutes walk test | 30 days, 6- and 12 months | Change in 6-minutes' walk test |
| Improvement of quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ) | 30 days, 6-, and 12-months | Improvement of quality of life by means of KCCQ. KCCQ is a 23-item, self-administered questionnaire |
| Improvement of quality of life by EQ-5D | 30 days, 6-, and 12-months | 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. |
| NYHA improvement | 3-, 6- and 12-months | Change in clinical status assessed by means of a decrease in NYHA functional class |
| All cause mortality | 30 days, 3-, 6- and 12-months post procedure | All cause mortality |
Countries
France, Germany, Netherlands
Outcome results
None listed