Five-year Outcomes of Rapid-deployment Aortic Valve Replacement With the Edwards Intuity TM Valve
NCT ID: NCT04696926
Last Updated: 2021-01-06
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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COMPLETED
170 participants
OBSERVATIONAL
2019-04-01
2020-12-30
Brief Summary
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This report presents 5-year outcomes of the rapid-deployment Edwards Intuity TM valve in a single-center prospective study.
Methods:
All consecutive patients who underwent an aortic valve replacement with an Edwards Intuity TM bioprosthesis at La Timone Hospital, Marseille, France, were prospectively included between July 2012 and June 2015 and were followed for 5 years. The primary outcome was overall mortality at 5 years.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients who underwent an aortic valve replacement
Edwards Intuity TM Valve implantation
aortic valve replacement with an Edwards Intuity TM bioprosthesis
Interventions
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Edwards Intuity TM Valve implantation
aortic valve replacement with an Edwards Intuity TM bioprosthesis
Eligibility Criteria
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Inclusion Criteria
* For severe aortic valve stenosis or severe aortic regurgitation
* Including reoperation and combined surgery
* Between July 2012 and June 2015
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Locations
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Assistance Publique Hôpitaux de Marseille
Marseille, , France
Countries
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Other Identifiers
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CIL 2019-48
Identifier Type: -
Identifier Source: org_study_id
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