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

Recruiting now

Conditions studied: Mitral Valve Replacement

In brief

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.

Key facts

Study ID

NCT07059793

Run by

Edwards Lifesciences

People needed

250

Starts

2025-07-08

Expected to finish

2038-12-01

Last updated by the study team

2025-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.)
• Participating in a drug or device study that has not reached its primary endpoint. Note: Participation in national registries is not an exclusion.

Where it is running

• Fuwai Central China Cardiovascular Hospital — Zhengzhou, Henan, China (enrolling)
• Wuhan Asia Heart Hospital — Wuhan, Hubei, China (enrolling)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (enrolling)
• Nanjing First Hospital — Nanjing, Jiangsu, China (enrolling)
• The First Affiliated Hospital of XI'an Jiaotong University — Xi'an, Shaanxi, China (enrolling)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (enrolling)
• Ningbo Medical Center Lihuili Hospital — Ningbo, Zhejiang, China (enrolling)
• Beijing Anzhen Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Fuwai Hospital, CAMS & PUMC — Beijing, Beijing Municipality, China (enrolling)
• Xiamen Cardiovascular Hospital Xiamen University — Xiamen, Fujian, China (enrolling)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (enrolling)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)

Full record on ClinicalTrials.gov

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