Ignite Creation Date:
2024-05-06 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03481387
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2018-03-22
Brief Title:
PERCEVAL S Valve Clinical Study for Chinese Registration
Sponsor:
Corcym Srl
Organization:
Corcym Srl
Study Overview
Official Title:
PERCEVAL S Valve Clinical Study for Chinese Registration
Status:
ACTIVE_NOT_RECRUITING
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:
PERFECT
Brief Summary:
This is a prospective open single arm multi-center clinical study in China The primary objective of this study is to demonstrate the safety and effectiveness of the PERCEVAL S heart valve when used to replace a diseased native or malfunctioning prosthetic aortic valve in the indicated Chinese population for tissue heart valve replacement and suitable to the PERCEVAL S valve
The secondary objectives are to collect all relevant device and subject demographics procedural and hospital discharge short and long-term data as described in the secondary endpoints section
The secondary objectives are to collect all relevant device and subject demographics procedural and hospital discharge short and long-term data as described in the secondary endpoints section
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None