Aortic Valve Stenosis Clinical Trial
Official title:
Randomized Comparison of Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
This study is a randomised comparison of apical stent valve treatment versus conventional valve surgery in patients with severe aortic valve stenosis.
The purpose of the study is to compare the new established apical stent valve treatment with
conventional surgical intervention using biological valve prostheses in patients with severe
aortic valve stenosis.
The Edwards-SAPIENTM Transcatheter Heart Valve (Edwards Lifesciences, Irvine, CA) will be
used in the stent valve group. The Carpentier-Edwards-Perimount Heart Valve (Edwards
Lifesciences, Irvine, CA) will be recommended for the conventional surgery group.(Edwards
Lifesciences, Irvine, CA).
Heart centres in the Nordic region with experience (>10 cases) in apical stent valve
treatment and in conventional surgical treatment of high risk patients with aortic valve
stenosis. The study will be initiated at Aarhus University Hospital, Skejby, Denmark.
Study hypothesis:
As compared to conventional aortic valve substitution in patients aged >75 years, apical
stent valve treatment reduces the rates of death, cerebrovascular insult (CVI) and need of
dialysis for renal failure 1 month after the treatment.
Primary clinical end-point:
Combined end-point consisting of death, CVI and/or renal failure with need for
haemodialysis, 1 month after index treatment.
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