NCT00329667

Observational Study of Prosthetic Tissue Aortic and Mitral Heart Valve

An Observational, Prospective Evaluation of the SJM Epic Valve

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 761 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Valvular Heart Disease

Interventions

Type	Name	Description
DEVICE	EPIC	Surgical replacement of a diseased, damaged, or malfunctioning native or prosthetic aortic and/or mitral heart valves

Timeline

• Start date: 2003-01-01
• Primary completion: 2006-03-01
• Completion: 2008-09-01
• First posted: 2006-05-25
• Last updated: 2019-02-04