Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
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|ClinicalTrials.gov Identifier: NCT00986193|
Recruitment Status : Terminated (By recommendation from the Data and safety monitoring board)
First Posted : September 29, 2009
Last Update Posted : June 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Stenosis||Procedure: Transapical Aortic Valve Implantation Procedure: Conventional Aortic Valve Surgery||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Comparison of Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2016|
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
- Death, CVI and/or renal failure requiring any dialysis [ Time Frame: 1 month ]
- Echocardiographic results, valve performance [ Time Frame: 1 month with subseguent followup ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986193
|Aarhus University Hospital, Skejby|
|Aarhus N, Region Midtjylland, Denmark, 8200|
|Principal Investigator:||Evald H Christiansen, MD||Skejby Hospital, Aarhus, Denmark|