Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
|Aortic Valve Stenosis||Procedure: Transapical Aortic Valve Implantation Procedure: Conventional Aortic Valve Surgery|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Randomized Comparison of Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis|
- Death, CVI and/or renal failure requiring any dialysis [ Time Frame: 1 month ]
- Echocardiographic results, valve performance [ Time Frame: 1 month with subseguent followup ]
|Study Start Date:||December 2008|
|Study Completion Date:||April 2016|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Conventional Aortic Valve Surgery
Insertion of a biological valve
Procedure: Conventional Aortic Valve Surgery
Operation using heart-lung machine, with insertion of a biological artificial heart valve
Experimental: Transapical Aortic Valve Implantation
Transapical implantation of an Edwards SAPIENtm valve
Procedure: Transapical Aortic Valve Implantation
Insertion of a stent valve using catheter-based technique through a mini thoracotomy
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986193
|Aarhus University Hospital, Skejby|
|Aarhus N, Region Midtjylland, Denmark, 8200|
|Principal Investigator:||Evald H Christiansen, MD||Skejby Hospital, Aarhus, Denmark|