Prospective, Single-arm Pivotal Study for the Treatment of Subjects with Severe Symptomatic Calcific Aortic Valve Stenosis Using Valvosoft® Non-Invasive Ultrasound Therapy (NIUT)
- Conditions
- Calcified Heart valve10046973
- Registration Number
- NL-OMON53861
- Lead Sponsor
- CARDIAWAVE SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
A subject must meet following criteria to be enrolled in the investigation:
1. Subject suffering from severe symptomatic calcific aortic valve stenosis; 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; 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)
A subject must not meet any of the following criteria to be enrolled in the
investigation: 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
the 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). 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 <12
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. 21. Subjects who do not have
Social Security and who are under legal restraint 22. Subjects who cannot read
or write or are mentally not or partially capable of giving informed consent.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety: Rate of MACE <20% (NIM 5%) at 30-days post-procedure Performance:<br /><br>Improvement in clinical status assessed by means of a decrease in NHYA<br /><br>functional class at 30 days post procedure</p><br>
- Secondary Outcome Measures
Name Time Method