Clinical Trial: Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Randomized Comparison of Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
Brief Summary: This study is a randomised comparison of apical stent valve treatment versus conventional valve surgery in patients with severe aortic valve stenosis.
Detailed Summary:
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.
Sponsor: Aarhus University Hospital Skejby
Current Primary Outcome: Death, CVI and/or renal failure requiring any dialysis [ Time Frame: 1 month ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Echocardiographic results, valve performance [ Time Frame: 1 month with subseguent followup ]
Original Secondary Outcome: Same as current
Information By: Aarhus University Hospital Skejby
Dates:
Date Received: September 25, 2009
Date Started: December 2008
Date Completion: April 2016
Last Updated: December 4, 2013
Last Verified: December 2013
