Severe Aortic Stenosis
Conditions
Interventions
None listed
Sponsors
SYMETIS S.A.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients 70 years of age and older 2. Additive EuroSCORE * 9 3. Severe aortic stenosis characterized by mean aortic gradient > 40 mmHg or peak jet velocity > 4.0 m/s or aortic valve area of *1.0 cm2 4. NYHA Functional Class > II 5. Aortic annulus diameter from * 21mm up to * 27mm by TEE 6. Patient willing to participate in the study and provides signed informed consent
Exclusion criteria
Exclusion criteria: 1. Congenital unicuspid or bicuspid aortic valve 2. Severe eccentricity of calcification 3. Severe mitral regurgitation (> 2°) 4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring 5. Severe transapical access problem, non-reachable LV apex 6. Previous surgery of the LV using a patch, such as the Dor procedure 7. Presence of apical LV thrombus 8. ECHO evidence of intracardiac mass, thrombus, or vegetation 9. AMI within 1 month prior to the procedure 10. PCI within 1 month prior to the procedure 11. Previous TIA or stroke in the last 3 months 12. Untreated coronary artery disease (CAD) requiring revascularization 13. Hemodynamic instability: systolic pressure 2.5 mg/dL or renal dialysis 24. Neurological disease severely affecting ambulation or daily functioning 25. Senile dementia 26. Another surgical or percutaneous procedure scheduled at the same time 27. Emergency procedure pre-implant 28. Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: Freedom from all-cause mortality at 30 days follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: 1. Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months 2. Functional improvement from baseline as per NYHA functional classification at 30 days and at 12 months 3. Procedural success post-implant 4. Device success at 30 days and at 12 months | — |
Countries
Netherlands
Outcome results
None listed