Aortic Valve Disease
Conditions
Brief summary
A prospective single arm study evaluating feasibility and safety of a catheter-based transapical implantation of the Ventor Embracer™ aortic valve bioprosthesis in patients with severe aortic valve disease, specifically aortic stenosis, who are at elevated risk for standard surgical valve replacement.
Interventions
DEVICEVentor Embracer
Implantation of Ventor Embracer
Sponsors
Ventor Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient understands the implications of participating in the study and provides informed consent 2. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone 3. Age \>75 years 4. Severe, aortic stenosis (echocardiographically derived mean gradient \> 40 mm Hg, and/or jet velocity \> 4m/s, or an initial aortic valve area of \< 0.8 cm2) 5. Symptoms related to the aortic valve disease, as demonstrated by NYHA Functional Class II or greater 6. EuroSCORE scale of \>9 points indicating a predicted risk for mortality of \>11% according to the logistic EuroSCORE 7. Echocardiographically determined anteroposterior aortic annulus diameter of \>19 and \<23 mm 8. Echocardiographically determined sinotubular junction diameter of ≥23 mm
Exclusion criteria
1. Congenital unicuspid or bicuspid aortic valve 2. Fused commissures 3. Severe eccentricity of calcification 4. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 5. Severe left ventricular dysfunction (LVEF \< 25%) 6. More than mild right ventricular dysfunction 7. Hypertrophic obstructive cardiomyopathy 8. Moribund patients, or patients with a noncardiac disease limiting by itself life expectancy to less than 12 months 9. Known hypersensitivity or contraindication to any study medication 10. Known sensitivity to contrast medium that cannot be adequately controlled with pre-medication 11. Known allergy or sensitivity to Nitinol 12. Sepsis, or acute endocarditis 13. Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy. 14. Renal insufficiency and/or end stage renal disease requiring chronic dialysis 15. Liver disease as indicated by jaundice, ascites, ALT/AST \> 3 x ULN, elevation of total bilirubin \> 1.5 mg/dl, albumin \< 3.0 g/l, or INR \> 1.5 (if not on anticoagulation). 16. Significant lung disease (e.g. FEV1 \< 1.2L or FEV1 \< 50%). 17. Active peptic ulcer or GI bleeding within 3 months from the planned index procedure 18. Untreated clinically significant coronary artery disease requiring revascularisation 19. Cardiogenic shock, suspected cardiogenic shock, or hemodynamic instability requiring inotropic support or mechanical heart assistance 20. Peripheral vascular disease, including abdominal and thoracic aortic disease, which could pose a problem for eventual transarterial mechanical support (e.g. Intraaortic Balloon Pump) 21. Need for emergency surgery, cardiac or noncardiac 22. History of myocardial infarction in the last 6 weeks. 23. History of TIA or stroke in the last 6 months. 24. Any therapeutic invasive cardiac procedure, except aortic balloon valvuloplasty, performed within 30 days from the planned index procedure, or 6 months, in case of implantation of drug-eluting stents. 25. Uncontrolled atrial fibrillation 26. Pre-existing aortic valve replacement 27. Severe (greater than 3+) mitral regurgitation 28. Severe (greater than 3+) aortic regurgitation 29. Patient is currently enrolled in another investigational device or drug trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stable device placement and adequate function as assessed by angiography and echocardiography immediately post-procedure | day one |
| A composite of any death, myocardial infarction, or disabling stroke at 30 days post-procedure | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Any of the following adverse events: death, disabling stroke, repeat aortic valve procedure or endocarditis at 6 months | 6 months |
| Freedom from death at 1 year | 1 year |
| Device success and the absence of periprocedural MACCEs at post-operative day 1 | day one |
| Peak & mean pressure gradient, derived calculated measures of prosthetic valve function, aortic regurgitation - assessed by echocardiography immediately after deployment, at POD 1, 30 days, 6 months and 5 years annually | 5 years |
| Functional improvement from baseline per New York Heart Association (NYHA) functional classification at 30 days, 6 months and 1 year | 1 year |
| Any of the following adverse events: death, myocardial infarction, disabling stroke, repeat aortic valve procedure, cardiogenic shock, or endocarditis at 30 days | 30 days |
Countries
Germany
Outcome results
None listed