NCT03851068

Early Feasibility Study for the Foldax Tria Aortic Heart Valve

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Foldax, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Disease
• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Foldax Tria Aortic Valve	Aortic Valve Replacement

Timeline

• Start date: 2019-06-18
• Primary completion: 2024-12-01
• Completion: 2026-12-01
• First posted: 2019-02-22
• Last updated: 2023-09-13

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study