Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-02 @ 3:36 AM
Study NCT ID:
NCT00329667
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2006-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Prosthetic Tissue Aortic and Mitral Heart Valve
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
An Observational, Prospective Evaluation of the SJM Epic Valve
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPIC
Brief 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
* adverse effect rates
* clinical status as indicated by NYHA functional classification
* hemodynamic performance
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: