Mitral Valve ReplacementMITRIS ChinaNCT07059793
MITRIS China Post Market Clinical Follow-up (PMCF) Study
An observational study of Mitral Valve Replacement, run by Edwards Lifesciences at 13 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Replacement
- What is being tested?
- MITRIS RESILIA Mitral Valve
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 13 sitesChina
- Study dates
- 8 Jul 2025to Dec 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Yongqiang Lai, Professor
- Recruiting
Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, 100037
Wei Fang, Professor
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Keli Huang, Professor
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Huiming Guo, Professor
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Xin Zhao, Professor
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
Qing Zhou, Professor
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210012
Xin Chen, Professor
- Recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315046
Guofeng Shao, Professor
- Recruiting
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022
Zhengdong Hua, Professor
- Recruiting
The First Affiliated Hospital of XI'an Jiaotong University
Xi'an, Shaanxi, 710061
Yang Yan, Professor
- Recruiting
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, 361008
Zhi Lin, Professor
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Xin Zhang, Professor
- Recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 451460
Zhaoyun Cheng, Professor
About this study
Official title: Post-Market Clinical Follow-up Study of Edwards Lifesciences MITRIS RESILIA Mitral Valve in Chinese Population
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.
Read the detailed description
The trial is a Multicenter, prospective, single-arm, post-market study designed to collect clinical outcomes in up to 250 Subjects who have received the MITRIS RESILIA Mitral Valve, Model 11400M.
- Conditions
- Mitral Valve Replacement
- Being tested
- MITRIS RESILIA Mitral Valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MITRIS RESILIA Mitral ValveDevice
Surgical replacement of native or prosthetic mitral valve.
| Study group | Role | What they receive |
|---|---|---|
| MITRIS RESILIA Mitral Valve | Subjects who received the MITRIS RESILIA Mitral Valve, Model 11400M Receives: Device: MITRIS RESILIA Mitral Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (6)
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.
Measured: 10 years
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.
Measured: 10 years
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.
Measured: 10 years
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.
Measured: 10 years
Adverse Events
Linearized rates of following key events will be presented in early (≤30 days) and late (>30 days) post-operative period. The outcomes will be adjudicated by Clinical Events Committee (CEC) up to 1 year and site-reported outcomes will be presented after completion of 1 year follow-up.
- Thromboembolism (Stroke, Transient Ischemia Attack (TIA), Non- Cerebral)
- Valve thrombosis
- Major bleeding
- Nonstructural Valve Dysfunction (NSVD)
- Structural Valve Deterioration (SVD)
- Endocarditis
- Valve related reintervention
- Death
Measured: 10 years
New York Heart Association (NYHA) Classification
Functional improvement from baseline for NYHA Class (all follow-up time points)
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.
Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).
Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).
Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.
Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start8 Jul 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve ReplacementStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Edwards (Shanghai) Medical Products Co. Ltd., Kun Tuo Medical Research and Development (Beijing) Co. Ltd., Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Sponsor
- Investigators
- Wei Feng, Professor, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059793
- Sponsor's protocol ID
- 2024-14
- Acronym
- MITRIS China
- Status last verified
- Dec 2025
- First submitted
- 13 Jun 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-up Study of Edwards Lifesciences MITRIS RESILIA Mitral Valve in Chinese Population
- ClinicalTrials.gov ID
- NCT07059793
- Acronym / sponsor ID
- MITRIS China / 2024-14
- Conditions
- Mitral Valve Replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Collaborators
- Edwards (Shanghai) Medical Products Co. Ltd., Kun Tuo Medical Research and Development (Beijing) Co. Ltd., Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2038 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial is a Multicenter, prospective, single-arm, post-market study designed to collect clinical outcomes in up to 250 Subjects who have received the MITRIS RESILIA Mitral Valve, Model 11400M.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MITRIS RESILIA Mitral Valve | – | Device: MITRIS RESILIA Mitral ValveSubjects who received the MITRIS RESILIA Mitral Valve, Model 11400M |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MITRIS RESILIA Mitral ValveSurgical replacement of native or prosthetic mitral valve. | Device | MITRIS RESILIA Mitral Valve |
Primary outcome
Primary Safety outcome - Kaplan Meier (KM) rate of valve related death or reintervention
Time frame: 1 year
Freedom from valve related death or valve related reintervention at 1 year as determined by the CEC.
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Average Mean Gradient Measurements
Time frame: 1 year
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.
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Average Peak Gradients Measurements
Time frame: 1 year
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.
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Transvalvular regurgitation
Time frame: 1 year
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.
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Paravalvular leak
Time frame: 1 year
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.
6 secondary outcomes
Performance outcome - Hemodynamics by echocardiography Subject's Average Mean Gradient Measurements
Time frame: 10 years
Performance outcome - Hemodynamics by echocardiography - Subject's Average Peak Gradients Measurements
Time frame: 10 years
Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Transvalvular regurgitation
Time frame: 10 years
Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Paravalvular leak
Time frame: 10 years
Adverse Events
Time frame: 10 years
New York Heart Association (NYHA) Classification
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Mitral Valve Replacement
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Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
Mitral Regurgitation (MR)
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Recruiting
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Mitral Valve Regurgitation
RecruitingObservational study
Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Feng, Professor principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Replacement, run by Edwards Lifesciences at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Honglei Sun (+8610 5641 0883, Honglei_Sun@edwards.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety outcome - Kaplan Meier (KM) rate of valve related death or reintervention (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.