NCT07059793 MITRIS China Post Market Clinical Follow-up (PMCF) Study
| NCT ID | NCT07059793 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Edwards Lifesciences |
| Condition | Mitral Valve Replacement |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-07-08 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2025-07-08 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. 18 years or older at the time of informed consent 2. Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery 3. Provide signed written informed consent prior to the study participation 4. Willingness to follow protocol requirements Exclusion Criteria: 1. Active endocarditis 3 months prior to the procedure 2. Stage 4 renal disease or requiring dialysis (eGFR \< 30 is excluded) 3. Less than 2-year life expectancy due to non-cardiovascular life-threatening disease 4. 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.) 5. Participating in a drug or device study that has not reached its primary endpoint. Note: Participation in national registries is not an exclusion.
Contact & Investigator
Wei Feng, Professor
PRINCIPAL INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Frequently Asked Questions
Who can join the NCT07059793 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Valve Replacement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07059793 currently recruiting?
Yes, NCT07059793 is actively recruiting participants. Contact the research team at Honglei_Sun@edwards.com for enrollment information.
Where is the NCT07059793 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Xiamen, China, Guangzhou, China and 9 additional locations.
Who is sponsoring the NCT07059793 clinical trial?
NCT07059793 is sponsored by Edwards Lifesciences. The principal investigator is Wei Feng, Professor at Chinese Academy of Medical Sciences, Fuwai Hospital. The trial plans to enroll 250 participants.