Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT05235568
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05235568
Study Brief:
Protocol Section:
NCT05235568