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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Implantation of Ventor Embracer
Prof. Thorsten Wahlers
Cologne, Germany
Prof. Jochen Schaefers
Homburg, Germany
Friedrich Mohr, MD
Leipzig, Germany
Stable device placement and adequate function as assessed by angiography and echocardiography immediately post-procedure
Time frame: day one
A composite of any death, myocardial infarction, or disabling stroke at 30 days post-procedure
Time frame: 30 days
Device success and the absence of periprocedural MACCEs at post-operative day 1
Time frame: day one
Any of the following adverse events: death, myocardial infarction, disabling stroke, repeat aortic valve procedure, cardiogenic shock, or endocarditis at 30 days
Time frame: 30 days
Any of the following adverse events: death, disabling stroke, repeat aortic valve procedure or endocarditis at 6 months
Time frame: 6 months
Freedom from death at 1 year
Time frame: 1 year
Functional improvement from baseline per New York Heart Association (NYHA) functional classification at 30 days, 6 months and 1 year
Time frame: 1 year
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
Time frame: 5 years
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