MITRIS China Post Market Clinical Follow-up (PMCF) Study
ConditionMitral Valve Replacement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEdwards Lifesciences
About this trial
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.
Eligibility criteria
Qualifiers
18 years or older at the time of informed consent
Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery
Provide signed written informed consent prior to the study participation
Willingness to follow protocol requirements
Disqualifiers
Active endocarditis 3 months prior to the procedure
Stage 4 renal disease or requiring dialysis (eGFR < 30 is excluded)
Less than 2-year life expectancy due to non-cardiovascular life-threatening disease
High predicted risk of mortality prior to procedure - STS Predicted Risk of Mortality (PROM) > 8 or Surgeon estimated risk of mortality of > 8 (STS PROM risk calculation score must be used for patients undergoing Isolated Mitral Valve Replacement (MVR) or MVR+ Coronary Artery Bypass Grafting (CABG). Surgeon estimated risk of mortality may only be used for patients who do not qualify for evaluation against those surgical models.)
Trial design
Treatments tested in this trial
- MITRIS RESILIA Mitral Valve
Treatment groups
250 Participants
are divided into 1 treatment groupSponsors and collaborators
Edwards Lifesciences
Lead sponsor
Edwards (Shanghai) Medical Products Co. Ltd.
Collaborator
Kun Tuo Medical Research and Development (Beijing) Co. Ltd.
Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator
Source ClinicalTrials.gov