Clinical Trial

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

Study acronym: MITRIS China
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-07-08; most recent amendment 2025-12-23.
Status change: Not Yet Recruiting → Recruiting 2025-07-23
Trial Details
NCT Number NCT07059793
Lead Sponsor Edwards Lifesciences
Collaborators: Edwards (Shanghai) Medical Products Co. Ltd., Kun Tuo Medical Research and Development (Beijing) Co. Ltd., Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions Mitral Valve Replacement
Enrollment 250 participants
Start Date 2025-07-08
Primary Completion 2028-12 (estimated)
Study Completion 2038-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-30