Comparison Between Three Types of Stented Pericardial Aortic Valves
NCT ID: NCT01522352
Last Updated: 2013-09-04
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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UNKNOWN
NA
165 participants
INTERVENTIONAL
2012-03-31
2013-12-31
Brief Summary
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Detailed Description
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Since March 2010, a new pericardial aortic valve has obtained a CE mark, allowing cardiac surgery centers in Europe to implement it in humans.
Hemodynamic performance of different biologic valves has never been measured. This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand.
Conditions
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Keywords
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Study Design
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PARALLEL
NONE
Study Groups
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pericardial aortic valves
Comparison of short and mid-term hemodynamic performance between three types of stented pericardial aortic valves: Trifecta aortic valve (St. Jude Medical), Mitroflow aortic valve (Sorin Group), Magna Ease (Edwards Lifesciences)
Aortic valve replacement by bioprosthesis
Comparison of short and mid-term hemodynamic performance between three types of stented pericardial aortic valves: Trifecta aortic valve (St. Jude Medical), Mitroflow aortic valve (Sorin Group), Magna Ease (Edwards Lifesciences)
Interventions
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Aortic valve replacement by bioprosthesis
Comparison of short and mid-term hemodynamic performance between three types of stented pericardial aortic valves: Trifecta aortic valve (St. Jude Medical), Mitroflow aortic valve (Sorin Group), Magna Ease (Edwards Lifesciences)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
85 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Abbott Medical Devices
INDUSTRY
Sorin group, Italy
UNKNOWN
Ministry of Health, France
OTHER_GOV
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Kasra AZARNOUSH, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Patrick LACARIN
Role: primary
References
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Azarnoush K, Pereira B, Duale C, Dorigo E, Farhat M, Innorta A, Dauphin N, Geoffroy E, Chabrot P, Camilleri L. Comparison between three types of stented pericardial aortic valves (Trivalve trial): study protocol for a randomized controlled trial. Trials. 2013 Dec 3;14:413. doi: 10.1186/1745-6215-14-413.
Other Identifiers
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CHU-0109
Identifier Type: -
Identifier Source: org_study_id