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Clinical Trial Summary

This study is a multi-center, prospective, non-randomized, observational study. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic valve.


Clinical Trial Description

This study is a multi-centered, multi-country, prospective, non-randomized, observational study, without concurrent or matched controls, conducted under a common protocol. Bayesian methods will be used for the design and analysis of this study. The Bayesian model will determine if the data for the valve configurations are poolable. Bayesian methods also provide a means of determining the appropriate stopping time for the study based on the amount of information generated. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic Valve by establishing the following:

- adverse effect rates

- clinical status as indicated by NYHA functional classification

- hemodynamic performance ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00329667
Study type Interventional
Source Abbott Medical Devices
Contact
Status Completed
Phase N/A
Start date January 2003
Completion date September 2008

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