Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569602
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System TRISCEND III EU
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective single-arm multi-center real-world study of an the Edwards EVOQUE system
Detailed Description:
This is a prospective single-arm multi-center real-world study of an approved device Up to 500 patients will be enrolled in this study at up to 45 sites in Europe All enrolled patients will be assessed at the following intervals baseline index procedure discharge or 7-days post-index procedure whichever occurs first 30 days 1 year and annually through 5 years
Study enrollment is expected to last approximately 2-4 years followed by 5 years of follow-up
Study enrollment is expected to last approximately 2-4 years followed by 5 years of follow-up
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