Ignite Creation Date:
2024-05-06 @ 10:14 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03200574
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2017-06-09
Brief Title:
Behavior of Valve Leaflets Following Aortic Valve Implant
Sponsor:
Corcym Srl
Organization:
Corcym Srl
Study Overview
Official Title:
Behavior of Valve Leaflets and the Incidence of Reduced Mobility Post-surgical Aortic Valve Implant
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:
BELIEVE
Brief Summary:
This is a prospective interventional multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant
Detailed Description:
This is a prospective interventional multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant on patients that are off anticoagulation for at least 30 days A minimum of 75 subjects with evaluable 4D CT scans will be enrolled at approximately 11 investigational sites where the devices are commercially available For asymptomatic subjects PIs and subjects will be blinded from the CT imaging results and from the Core Lab findings
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?:
True
Is an FDA AA801 Violation?:
None