severe aortic valve stenosis / severely calcified aortic valve has caused a stenosis
Conditions
Interventions
Valvosoft PCUT consists in delivering trans-thoracically precisely focused and
controlled short ultrasound pulses (
Sponsors
CARDIAWAVE SA.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subjects suffering from severe symptomatic aortic valve stenosis according to ESC 2017 definition, including subjects with a bicuspid valve. 2. Patient is not eligible for TAVR/SAVR according to local Heart Team. 3. Age >=18 years. 4. Subjects who are willing to provide a written informed consent prior to participating in this clinical investigation. 5. Subjects who can comply with the study follow-up or other study requirements. 6. Patient is eligible for the Valvosoft procedure according to CRC.
Exclusion criteria
Exclusion criteria: 1. Subjects with any electrical device implanted. 2. Subjects with unstable arrhythmia not controlled by medical treatment. 3. Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position. 4. Subjects with complex congenital heart disease. 5. Chest deformity. 6. Cardiogenic shock. 7. History of heart transplant. 8. Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after treatment. 9. Thrombus in heart. 10. Acute myocardial infarction, stroke or transient ischemic attack (TIA) within one month prior to enrolment*. 11. Subjects who are pregnant or nursing. 12. Subjects who are participating in another research study for which the primary endpoint has not been reached.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Rate of procedure related mortality up to 30 days post-procedure. Performance: 1. Level of improvement in leaflet mobility by means of decrease in transvalvular pressure gradient (PG) immediately post procedure compared to baseline (echocardiography). 2. Level of decrease in severity of aortic stenosis by means of increase in aortic valve area (AVA) (echocardiography) immediately post procedure compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: 1. Rate of MAEs peri procedural and at 1, 3, 6, 12 and 24 months post procedure. 2. All-cause mortality at 1, 3, 6, 12 and 24 months post procedure. 3. Rate of stroke at 1, 3, 6, 12 and 24 months. 4. Rate of all adverse events up to 24 months. Performance: Device usability 1. User handling (questionnaire for operator + procedure duration). 2. Long term maintenance of improvement of AVA and PG at 1, 3, 6, 12 and 24 months. The 6 months assessment being an important secondary endpoint for regulatory purposes. Effectiveness: 1. Improvement of clinical status assessed by means of NYHA functional class, presyncope/syncope and angina at 1, 3, 6, 12 and 24 months. 2. Improvement of quality of life by means of KCCQ at 1, 3, 6, 12 and 24 months. | — |
Countries
Netherlands
Outcome results
None listed