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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Wei Feng, Professor — Chinese Academy of Medical Sciences, Fuwai Hospital
• Study coordinator: Honglei Sun
• Email: Honglei_Sun@edwards.com
• Phone: +8610 5641 0883

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Replacement of the Native Mitral Valve With the ReValve System

  This study tests the ReValve System to replace a diseased mitral valve in adults with symptomatic mitral regurgitation.

  Recruiting at 2 sites Early Phase 1 ReValve Solutions Inc. · São Paulo, São Paulo and 1 other locations · NCT07601269

• Abbott Cephea registry for mitral valve disease

  Collects clinical information on adults with symptomatic mitral valve disease to see how correcting the valve with the Cephea system affects outcomes for patients who might be candidates for transcatheter mitral valve replacement.

  Recruiting at 24 sites Abbott Medical Devices · Birmingham, Alabama and 23 other locations · NCT07069673

• MRace Implant: A first look at fixing the mitral valve to reduce regurgitation

  This single-arm study tests whether the MRace Implant and Delivery System can safely place a prosthesis to reduce severe mitral regurgitation in high-risk patients who may not be good candidates for open-heart surgery.

  Recruiting at 4 sites Polares Medical SA · Tbilisi and 3 other locations · NCT07796659

• Mitral Valve Calcification Imaging with TrueVue 3D Light Rendering

  This study tests how well three-dimensional transesophageal echocardiography with TrueVue transillumination detects mitral valve calcifications compared with CT in adults.

  Recruiting Centro Cardiologico Monzino · Milan, Milan · NCT07612553

• Tracking progression and consequences of heart valve disease

  This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.

  Recruiting at 15 sites Second Affiliated Hospital, Zhejiang University, School of Medicine · Fuzhou, Fujian and 14 other locations · NCT07267117

• Surgical implantation of a polymer prosthetic mitral or aortic valve

  This will test a surgically implanted polymer heart valve to see if it is safe and works well for adults who need mitral or aortic valve replacement.

  Recruiting Mitrassist Lifesciences Limited Co., Ltd. · Shanghai, Shanghai Municipality · NCT07097740

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.