Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
NCT ID: NCT00986193
Last Updated: 2017-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
72 participants
INTERVENTIONAL
2008-12-31
2016-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional Aortic Valve Surgery
Insertion of a biological valve
Conventional Aortic Valve Surgery
Operation using heart-lung machine, with insertion of a biological artificial heart valve
Transapical Aortic Valve Implantation
Transapical implantation of an Edwards SAPIENtm valve
Transapical Aortic Valve Implantation
Insertion of a stent valve using catheter-based technique through a mini thoracotomy
Interventions
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Transapical Aortic Valve Implantation
Insertion of a stent valve using catheter-based technique through a mini thoracotomy
Conventional Aortic Valve Surgery
Operation using heart-lung machine, with insertion of a biological artificial heart valve
Eligibility Criteria
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Inclusion Criteria
* 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
* Earlier cardiac surgery
* Myocardial infarction within 24 hours
* Kidney failure requiring any dialysis
* Ongoing infection
* Acute surgery
* Allergy to ASA or Clopidogrel
75 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Danish Heart Foundation
OTHER
Aarhus University Hospital Skejby
OTHER
Responsible Party
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Evald Hoej Christiansen
MD
Principal Investigators
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Evald H Christiansen, MD
Role: PRINCIPAL_INVESTIGATOR
Skejby Hospital, Aarhus, Denmark
Locations
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Aarhus University Hospital, Skejby
Aarhus N, Central Jutland, Denmark
Countries
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Other Identifiers
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Skejby 2008-1
Identifier Type: -
Identifier Source: org_study_id
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