Brief Title
Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
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 Description
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.
Study Type
Interventional
Primary Outcome
Death, CVI and/or renal failure requiring any dialysis
Secondary Outcome
Echocardiographic results, valve performance
Condition
Aortic Valve Stenosis
Intervention
Transapical Aortic Valve Implantation
Study Arms / Comparison Groups
Conventional Aortic Valve Surgery
Description: Insertion of a biological valve
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
72
Start Date
December 2008
Completion Date
April 2016
Primary Completion Date
April 2011
Eligibility Criteria
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
Gender
All
Ages
75 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Evald H Christiansen, MD, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT00986193
Organization ID
Skejby 2008-1
Responsible Party
Principal Investigator
Study Sponsor
Aarhus University Hospital Skejby
Collaborators
Odense University Hospital
Study Sponsor
Evald H Christiansen, MD, Principal Investigator, Skejby Hospital, Aarhus, Denmark
Verification Date
May 2017