NCT06192706

Clinical Investigation for the Foldax Tria Aortic Heart Valve- India

Clinical Investigation for the Foldax Tria Aortic Heart Valve India

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Foldax, Inc · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to conduct a clinical investigation of the Foldax Tria Aortic Valve to collect evidence on the device's safety and performance.

Detailed description

The Foldax Tria Aortic Heart Valve is indicated as a replacement for diseased, damaged, or malfunctioning native aortic heart valve via open heart surgery. The study is a single open are label non-randomized multi- center clinical trial. Up to 10 sites in the country of India will enroll up to 50 patients. These patients will follow the study schedule for 1 year after implantation.

Conditions

• Aortic Valve Stenosis
• Aortic Valve Insufficiency
• Aortic Valve Calcification
• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	Foldax Tria Aortic Valve	Aortic Valve Replacement

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-07-01
• Completion: 2024-09-01
• First posted: 2024-01-05
• Last updated: 2024-01-05

Locations

10 sites across 1 country: India