Ignite Creation Date:
2024-05-05 @ 9:23 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00876525
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2009-04-03
Brief Title:
Clinical Investigation of the Freedom SOLO Stentless Heart Valve
Sponsor:
Corcym Srl
Organization:
Corcym Srl
Study Overview
Official Title:
Clinical Investigation of the Freedom SOLO Stentless Heart Valve
Status:
COMPLETED
Status Verified Date:
2024-03
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:
None
Brief Summary:
This is a trial to demonstrate the safety and effectiveness of the Freedom SOLO heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis
Detailed Description:
Freedom SOLO study is a prospective non-randomized multicenter trial on the Freedom SOLOvalve implanted in patients requiring aortic valve replacement The study was conducted at 18 centers in Europe
The study was based on single sample hypothesis testing that allows comparison of observed morbid event rates to objective performance criteria OPCs Based on the guidelines established by the US Food and Drug Administration FDA the minimum sample size for this study was 800 valve-years which is the minimum amount of data needed to test against the OPC of 12 patient-year
The study was based on single sample hypothesis testing that allows comparison of observed morbid event rates to objective performance criteria OPCs Based on the guidelines established by the US Food and Drug Administration FDA the minimum sample size for this study was 800 valve-years which is the minimum amount of data needed to test against the OPC of 12 patient-year
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