Ignite Creation Date:
2024-05-05 @ 9:19 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00860730
Status:
COMPLETED
Last Update Posted:
2022-07-08
First Post:
2009-03-11
Brief Title:
PERCEVAL Pivotal Trial
Sponsor:
Corcym Srl
Organization:
Corcym Srl
Study Overview
Official Title:
PERCEVAL Pivotal Trial
Status:
COMPLETED
Status Verified Date:
2019-01
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:
The clinical investigation is designed as a prospective and non-randomised study on a maximum of 150 patients This study will be conducted at Investigational Centres in the European Community A minimum number of 8 European Centres will be involved in the clinical investigation A minimum of 15 patients will be enrolled at each Investigational Centre The clinical follow-up requires evaluations at discharge or 30 days if the patient is still hospitalized 3-6 and 12 months following the procedureThe primary objective of this clinical investigation is to assess the performance of the Perceval S valve at 3-6 months after implantation in high surgical risk patients who require a surgical intervention to replace the aortic valve
Detailed Description:
The design of the Perceval S prosthesis stems from the intention to offer an alternative to traditional flexible prostheses stented and stentless biological valves using conventional open-heart surgery As a result of the sutureless implant procedure in fact patients could benefit from
Reducing aortic clamp times with subsequent overall reduction of surgical timing and therefore reduction in related risks Avoiding to pass the stitches through the annulus and sutures knotting with consequent less risk of tearing aortic annulus and wall damaging the bundle of His embolizing foreign material in the vascular system
Reducing aortic clamp times with subsequent overall reduction of surgical timing and therefore reduction in related risks Avoiding to pass the stitches through the annulus and sutures knotting with consequent less risk of tearing aortic annulus and wall damaging the bundle of His embolizing foreign material in the vascular system
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