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Clinical Trial Summary

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.


Clinical Trial Description

According to the French database Society for Thoracic and Cardiovascular Surgery, 11,621 patients underwent aortic valve replacement in 2007. Over 77% of biologic prosthetic valves were used. Among these biologic valves, those in pericardium are mainly used in all French cardiac surgery centers.

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. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


NCT number NCT01522352
Study type Interventional
Source University Hospital, Clermont-Ferrand
Contact Patrick LACARIN
Phone 04 73 75 11 95
Email placarin@chu-clermontferrand.fr
Status Recruiting
Phase N/A
Start date March 2012
Completion date December 2013

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