Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-01-04 @ 5:17 PM
Study NCT ID:
NCT03851068
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-13
First Post:
2019-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Feasibility Study for the Foldax Tria Aortic Heart Valve
Sponsor:
Foldax, Inc
Organization:
Study Overview
Official Title:
Early Feasibility Study for the Foldax Tria Aortic Heart Valve
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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 purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Aortic Valve to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.
Detailed Description:
The Foldax Polymer Aortic Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native aortic heart valve via open heart surgery. This is a first in human study conducted under US FDA's Early Feasibility Investigational Device Exemption and will enroll up to 40 patients. These patients will be followed up to 5 years after implantation.
Study Oversight
Has Oversight DMC:
True
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?: