Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06608823
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
ARTIST Aortic Regurgitation Trial Investigating Surgery Versus Trilogy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Study to Assess Safety and Effectiveness of the JenaValve Trilogy Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients with Aortic Regurgitation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
ARTIST
Brief Summary:
To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve THV System compared with surgical aortic valve replacement SAVR for treatment of subjects with clinically significant native aortic regurgitation AR
Detailed Description:
None
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