Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis

Study Overview
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Brief Summary
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This study is a randomised comparison of apical stent valve treatment versus conventional valve surgery in patients with severe aortic valve stenosis.

Detailed Description
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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.

Official Title
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Randomized Comparison of Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Procedure: Transapical Aortic Valve Implantation
* Procedure: Conventional Aortic Valve Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Significant aortic valve stenosis (valve area < 1cm2) Age > 75 (years Aarhus University Hospital, Skejby) Age > 80 years (other participating centres) Operable by conventional surgery AND transapical stent valve implantation Expected survival > 1 year following successful treatment Accept of participation and in follow-up investigations after adequate information Informed consent Exclusion Criteria: Coronary artery disease requiring PCI or CABG Earlier cardiac surgery Myocardial infarction within 24 hours Kidney failure requiring any dialysis Ongoing infection Acute surgery Allergy to ASA or Clopidogrel

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Aortic Valve Surgery<br>Insertion of a biological valve | Procedure: Conventional Aortic Valve Surgery<br>* Operation using heart-lung machine, with insertion of a biological artificial heart valve<br>|
| Experimental: Transapical Aortic Valve Implantation<br>Transapical implantation of an Edwards SAPIENtm valve | Procedure: Transapical Aortic Valve Implantation<br>* Insertion of a stent valve using catheter-based technique through a mini thoracotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death, CVI and/or renal failure requiring any dialysis |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiographic results, valve performance |  | 1 month with subseguent followup | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Valve Stenosis, Stent Valve, Biological Aortic Valve Prosthesis