Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329667
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2006-05-23
Brief Title:
Observational Study of Prosthetic Tissue Aortic and Mitral Heart Valve
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None