severe heart valve contraction symptomatic aortic valve stenosis
Conditions
Interventions
All study subjects will receive a non-CE marked heartvalve.
European safety and performance study
Symptomatic patient with severe aortic stenosis
Sponsors
Edwards Lifesciences LLC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Heart team (including at least a cardiac surgeon and an interventional cardiologist) agrees on eligibility including assessment that TAVI is appropriate. 2. High surgical risk: 8 = II. 4. Severe symptomatic aortic stenosis requiring aortic valve replacement characterized by AVA 40mmHg (or peak aortic jet velocity > 4.0m/sec). 5. Study patient is an adult of legal consent age. 6. Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits. 7. If women of childbearing age, confirmation of negative pregnancy test
Exclusion criteria
Exclusion criteria: 1. Evidence of an acute myocardial infarction = 3 times normal in the absence of pathological Q waves), if no assay for CK-MB was performed, elevation of CK level to > 2 times normal without new Q waves is also considered a non-Q wave MI)]. 2. Untreated clinically significant coronary artery disease requiring revascularization. 3. Aortic valve is a congenital unicuspid or congenital bicuspid valve. 4. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+). 5. Preexisting bioprosthetic valve or ring in any position. 6. Leukopenia (WBC 26 mm as measured by CT. 13. Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure. 14. Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening. 15. Estimated life expectancy
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Device Success: Composite of absence of procedural mortality AND correct positioning of a single prosthetic heart valve into the proper anatomical location AND intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient =20 mmHg, EOA =20 mmHg, EOA =20 mmHg, EOA | — |
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality at 30 days post-index procedure | — |
Countries
Australia, New Zealand
Outcome results
None listed