Long-term follow-up after MITRIS RESILIA mitral valve replacement in China

Post-Market Clinical Follow-up Study of Edwards Lifesciences MITRIS RESILIA Mitral Valve in Chinese Population

This project will collect health outcomes to see if the MITRIS RESILIA mitral valve is safe and works well for adults in China who need a mitral valve replacement.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Edwards Lifesciences (industry)
• Locations: 13 sites (Beijing, Beijing Municipality and 12 other locations)
• Trial ID: NCT07059793 on ClinicalTrials.gov

What this trial studies

This is a multicenter, prospective, single-arm post-market follow-up enrolling up to 250 adults who receive the MITRIS RESILIA Mitral Valve (Model 11400M) for replacement of a native or prosthetic mitral valve. The study will collect acute and long-term safety and performance outcomes after surgery, including subjects with or without concomitant procedures. Data will be gathered at participating Chinese cardiac centers with scheduled follow-up visits to document clinical events, valve function, and survival. The intent is to describe real-world outcomes of the device in routine surgical practice.

Who should consider this trial

Good fit: Adults (age 18+) in China who have a dysfunctional native or prosthetic mitral valve and require surgical mitral valve replacement, who can provide informed consent and follow study visits, are eligible.

Not a fit: Patients with recent active endocarditis, severe renal failure (eGFR <30 or on dialysis), less than 2-year non-cardiac life expectancy, very high predicted surgical mortality risk, or participation in another drug trial are excluded and may not benefit from participation.

Why it matters

Potential benefit: If successful, the results could give patients and surgeons more confidence about the valve's safety and durability in the mitral position.

How similar studies have performed: Other clinical and post-market data on RESILIA tissue, particularly in the aortic position, have reported favorable early outcomes, but long-term mitral-specific data remain limited.

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.

Where this trial is running

Beijing, Beijing Municipality and 12 other locations

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

Study contacts

• Principal investigator: Wei Feng, Professor — Chinese Academy of Medical Sciences, Fuwai Hospital
• Study coordinator: Honglei Sun

Conditions: Mitral Valve Replacement