MITRIS China Post Market Clinical Follow-up (PMCF) Study
MITRIS China
Post-Market Clinical Follow-up Study of Edwards Lifesciences MITRIS RESILIA Mitral Valve in Chinese Population
1 other identifier
observational
250
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2025
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2025
CompletedStudy Start
First participant enrolled
July 8, 2025
CompletedFirst Posted
Study publicly available on registry
July 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2038
December 30, 2025
December 1, 2025
3.4 years
June 13, 2025
December 23, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Primary Safety outcome - Kaplan Meier (KM) rate of valve related death or reintervention
Freedom from valve related death or valve related reintervention at 1 year as determined by the CEC.
1 year
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Average Mean Gradient Measurements
Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.
1 year
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Average Peak Gradients Measurements
Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.
1 year
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Transvalvular regurgitation
Transvalvular leak is where a heart valve doesn't close properly, allowing blood to flow backward through the valve itself. Transvalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
1 year
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Paravalvular leak
Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
1 year
Secondary Outcomes (6)
Performance outcome - Hemodynamics by echocardiography Subject's Average Mean Gradient Measurements
10 years
Performance outcome - Hemodynamics by echocardiography - Subject's Average Peak Gradients Measurements
10 years
Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Transvalvular regurgitation
10 years
Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Paravalvular leak
10 years
Adverse Events
10 years
- +1 more secondary outcomes
Study Arms (1)
MITRIS RESILIA Mitral Valve
Subjects who received the MITRIS RESILIA Mitral Valve, Model 11400M
Interventions
Surgical replacement of native or prosthetic mitral valve.
Eligibility Criteria
Subjects from China who meet all the study inclusion criteria and none of the study exclusion criteria who undergo a mitral valve replacement with the Model 11400M heart valve and voluntary sign a consent form to agree to participate in the study.
You may qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029, China
Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, 100037, China
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, 361008, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 451460, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000, China
Nanjing First Hospital
Nanjing, Jiangsu, 210012, China
The First Affiliated Hospital of XI'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315046, China
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Feng, Professor
Chinese Academy of Medical Sciences, Fuwai Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2025
First Posted
July 11, 2025
Study Start
July 8, 2025
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2038
Last Updated
December 30, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share