VALVOSOFT® Pivotal Study

Not Applicable

Completed

• Conditions: Aortic Valve Calcification; Aortic Valve Stenosis

• Registration Number: NCT05235568
• Lead Sponsor: Cardiawave SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-1-20
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Subject suffering from severe symptomatic calcific aortic valve stenosis as defined<br> by ESC/EACTS guidelines for the management of valvular heart disease 2021; and<br><br> 2. Subject is not recommended by the local HEART Team for immediate TAVR/SAVR; or<br><br> 3. Subject who refuses TAVR/SAVR, documented by local HEART Team (not allowed in<br> France); and<br><br> 4. Age =18 years; and<br><br> 5. Subject willing to provide a written informed consent prior to participating in the<br> study; and<br><br> 6. Subject who can comply with the study follow-up or other study requirements; and<br><br> 7. Subject is eligible for the Valvosoft procedure according to Clinical Review<br> Committee (CRC).<br><br>Exclusion Criteria:<br><br> 1. Subject with severe aortic regurgitation; or<br><br> 2. Subject with unstable arrhythmia not controlled by medical treatment; or<br><br> 3. Subjects with implanted mechanical valve in any position or bio-prosthetic valve in<br> aortic position; or<br><br> 4. Subject has a chest deformity not allowing optimal placement of Valvosoft Applicator<br> and visualization of the aortic valve; or<br><br> 5. Cardiogenic shock or other hemodynamic instability; or<br><br> 6. Left Ventricular Ejection Fraction =30%; or<br><br> 7. Subject with mean AVAI <0,24 cm²/m2; or<br><br> 8. History of heart transplant; or<br><br> 9. Subject requiring other cardiac surgery procedures (bypass graft surgery, mitral<br> valve procedure, tricuspid valve procedure) within one month after Valvosoft<br> procedure; or<br><br> 10. Cardiac imaging evidence of vegetation; or<br><br> 11. Acute myocardial infarction (MI) within one month prior to enrolment; or<br><br> 12. Valve depth not suitable for NIUT (depth >125mm with respect to the Valvosoft<br> imaging probe); or<br><br> 13. Stroke or transient ischemic attack (TIA) =1 month prior to enrollment; or<br><br> 14. Subject who is pregnant, or plan to become pregnant during the 12-months study<br> follow-up period; or<br><br> 15. Subject who is participating in another research study for which the primary<br> endpoint has not been reached; or<br><br> 16. Balloon aortic valvuloplasty (BAV) =3 months prior to enrollment; or<br><br> 17. Current endocarditis; or<br><br> 18. Leukopenia (WBC <4000 cell/µL), anemia (Hgb <8 g/dL), thrombocytopenia (platelet<br> count <15.000 cell/µL), or history of coagulopathy or hypercoagulable state; or<br><br> 19. Life expectancy < 6 months due to non-cardiac co-morbid conditions; or<br><br> 20. Other medical, psychological, or social condition which, in the opinion of the<br> investigator, precludes the subject from study participation; or<br><br> 21. Subjects who do not have Social Security and who are under legal restraint; or<br><br> 22. Subjects who cannot read or write or are mentally not or partially capable of giving<br> informed consent.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety endpoint;Performance endpoint

Secondary Outcome Measures

Name	Time	Method
Rate of MACE;All cause mortality;Rate of Stroke;AVA change at 30 days;AVA change in severity;NYHA improvement;Change in 6 minutes walk test;Improvement of quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ);Improvement of quality of life by EQ-5D