NCT07059793

MITRIS China Post Market Clinical Follow-up (PMCF) Study

Post-Market Clinical Follow-up Study of Edwards Lifesciences MITRIS RESILIA Mitral Valve in Chinese Population

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Collect clinical outcomes on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures.

Detailed description

The trial is a Multicenter, prospective, single-arm, post-market study designed to collect clinical outcomes in up to 250 Subjects who have received the MITRIS RESILIA Mitral Valve, Model 11400M.

Conditions

• Mitral Valve Replacement

Interventions

Type	Name	Description
DEVICE	MITRIS RESILIA Mitral Valve	Surgical replacement of native or prosthetic mitral valve.

Timeline

• Start date: 2025-07-08
• Primary completion: 2028-12-01
• Completion: 2038-12-01
• First posted: 2025-07-11
• Last updated: 2025-12-30

Locations

13 sites across 1 country: China

Regulatory

• FDA-regulated device study