Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT06569602
Status:
RECRUITING
Last Update Posted:
2024-10-31
First Post:
2024-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
Sponsor:
Edwards Lifesciences
Organization:
Study Overview
Official Title:
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device
Status:
RECRUITING
Status Verified Date:
2024-10
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:
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?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: