Valvular Heart Disease Clinical Trial
Official title:
An Observational, Prospective Evaluation of the SJM Epic Valve
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.
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
;
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