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Clinical Trial Summary

This trial is designed to confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by New York Heart Association (NYHA) functional classification, hemodynamic performance, and hematology analysis.


Clinical Trial Description

The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study without concurrent or matched controls, designed to evaluate the safety and effectiveness of the Trifecta valve. A maximum of 120 subjects requiring aortic valve replacement will be implanted at a maximum of 6 investigational sites in Europe. The sample size is based on late patient-years of follow-up with a minimum of 400 late patient-years experience required. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00727181
Study type Interventional
Source Abbott Medical Devices
Contact
Status Completed
Phase N/A
Start date November 2007
Completion date December 2010

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