NCT06191718

Clinical Investigation for the Foldax Tria Mitral Valve- India

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Foldax, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

The Foldax Tria Mitral Heart Valve is indicated as a replacement for diseased, damaged, or malfunctioning native mitral 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 70 patients. The first two patients at each site, will be considered roll-in patients accounting for training. Up to 50 patients will be considered part of the treatment phase. These patients will follow the study schedule for 1 year after implantation.

Conditions

• Mitral Valve Disease
• Mitral Regurgitation
• Mitral Stenosis
• Mitral Valve Insufficiency

Interventions

Type	Name	Description
DEVICE	Mitral Valve Replacement	Foldax Mitral Valve Replacement

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2024-01-05
• Last updated: 2024-01-05

Locations

10 sites across 1 country: India