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Observational Study of Prosthetic Tissue Aortic and Mitral Heart Valve

2014-07-23 21:43:39 | BioPortfolio

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.

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

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Valvular Heart Disease

Intervention

EPIC

Status

Active, not recruiting

Source

St. Jude Medical

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:43:39-0400

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