NCT05526560

Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

A Prospective, Global Study Designed to Collect Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 504 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Collect real-world data 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

MOMENTIS is a prospective, observational, single-arm, multicenter global study designed to collect real-world clinical outcomes in up to 500 subjects who have received the MITRIS RESILIA Mitral Valve, Model 11400M.

Conditions

• Mitral Stenosis
• Mitral Valve Insufficiency

Interventions

Type	Name	Description
DEVICE	MITRIS RESILIA Mitral Valve, Model 11400M	Replacement of mitral valve with MITRIS RESLIA Mitral Valve

Timeline

• Start date: 2023-01-11
• Primary completion: 2028-01-01
• Completion: 2035-12-01
• First posted: 2022-09-02
• Last updated: 2026-04-14

Locations

34 sites across 4 countries: United States, Canada, Germany, United Kingdom

Regulatory

• FDA-regulated device study