Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06011148
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2023-08-01
Brief Title:
Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population
Sponsor:
Corcym Srl
Organization:
Corcym Srl
Study Overview
Official Title:
Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population
Status:
NOT_YET_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:
None
Brief Summary:
The objective of the study is to evaluate the safety information on the Perceval S sutureless prosthetic heart valve after the implantation for aortic valve disease
The study is designed as a post-market observational non-interventional retrospective and prospective registry
The study is designed as a post-market observational non-interventional retrospective and prospective registry
Detailed Description:
In order to monitor the ongoing safety of the Perceval S as part of regulatory requirements the study aims to retrospectively collect safety outcomes and performance data in patients with aortic valve disease implanted with Perceval S since 2022 The data will be used for regulatory purposes to support the re-certification of the valve in the Chinese market
Serious Adverse Events SAEs such as valve-related death structural valve deterioration cerebral thromboembolism stroke Transient Ischemic Attack non-cerebral thromboembolism major bleeding re-operation will be studied to describe the safety profile of the valve
Hemodynamic data from site reported echocardiography finding mean gradient peak gradient effective orifice area effective orifice area indexed incidence and degree of PVL and central leak at hospital discharge will also be evaluated Data of approximately 80 subjects will be collected in four clinical sites in China
Serious Adverse Events SAEs such as valve-related death structural valve deterioration cerebral thromboembolism stroke Transient Ischemic Attack non-cerebral thromboembolism major bleeding re-operation will be studied to describe the safety profile of the valve
Hemodynamic data from site reported echocardiography finding mean gradient peak gradient effective orifice area effective orifice area indexed incidence and degree of PVL and central leak at hospital discharge will also be evaluated Data of approximately 80 subjects will be collected in four clinical sites in China
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None