Aortic Valve Stenosis
Conditions
Keywords
symptomatic, aortic valve, stenosis, ultrasound, non-invasive
Brief summary
This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-man
Detailed description
CARDIAWAVE has developed a new non-invasive, real-time image-guided, therapeutic approach to treat patients suffering from Calcified Aortic Stenosis. CARDIAWAVE's Valvosoft device is a new ultrasound therapy based on a disruptive technology involving delivering an extremely precise and focused ultrasound beam to perform a reparative effect on the aortic valve leaflets, softening the valve's tissues, restoring leaflet mobility, and therefore improving the overall clinical status related to the aortic valve stenosis. This is a FIM study
Interventions
DEVICEUltrasound treatment of Calcified aortic valve
Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacement
Sponsors
Cardiawave SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Ultrasound treatment of calcified aortic valve stenosis
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects suffering from severe symptomatic aortic valve stenosis (including subjects with a bicuspid valve). 2. Patient is not eligible for TAVR/SAVR . 3. Age ≥18 years. 4. Subjects who are willing to provide a written informed consent prior to participating in the study. 5. Subjects who can comply with the study follow up or other study requirements. 6. Subject eligible according to Clinical Review Committee \-
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 (MI), 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 | Description |
|---|---|---|
| Safety: Rate of procedure related mortality at 30 days | 30 days post-procedure | Rate of procedure related mortality at 30 days |
| Device performance to modify valve structure as measured by echocardiography | Immediately post-procedure | Ability to modify the Aortic Valve Area (mm2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of clinical status | Up to 24 months | Improvement of New York Heart Association class (I-IV - stage of severity of heart failure - I=no symptoms, IV= symptoms at rest) at 1,3,6,12, and 24 months. |
| Number of all Adverse Events (AEs) | Up to 24 months | Rate of AE's reported at at 1, 3, 6, 12 and 24 months |
| All-cause mortality and major adverse events (MAE's) | Up to 24 months | Rate of all-cause mortality and MAE's peri and postprocedure and at 1, 3, 6, 12 and 24 months post operatively. |
| Improvement of quality of life | upto 24 months | Improvement of quality of life by means of Kansas City Cardiomyopathy Questionnaire at 1, 3, 6, 12 and 24 months |
| Long term maintenance of improvement of AVA and PG | upto 24 months | Long term maintenance of improvement of AVA and PG at 3, 6, 12 and 24 months |
| User handeling of Valvosoft | Immediately post-procedure | User handling (questionnaire for operator + procedure duration) immediately post-procedure |
| Non-disabling stroke | Up to 24 months | Rate of stroke at 1,3,6, 12 and 24 months |
Countries
France, Netherlands
Outcome results
None listed