Status:
TERMINATED
Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
Lead Sponsor:
Aarhus University Hospital Skejby
Collaborating Sponsors:
Odense University Hospital
Danish Heart Foundation
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
75+ years
Phase:
NA
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00986193
Start Date
December 1 2008
End Date
April 1 2016
Last Update
June 1 2017
Active Locations (1)
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1
Aarhus University Hospital, Skejby
Aarhus N, Central Jutland, Denmark, 8200