MITRIS China Post Market Clinical Follow-up (PMCF) Study
NCT ID: NCT07059793
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2025-07-08
2038-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MITRIS RESILIA Mitral Valve
Subjects who received the MITRIS RESILIA Mitral Valve, Model 11400M
MITRIS RESILIA Mitral Valve
Surgical replacement of native or prosthetic mitral valve.
Interventions
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MITRIS RESILIA Mitral Valve
Surgical replacement of native or prosthetic mitral valve.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Edwards (Shanghai) Medical Products Co. Ltd.
UNKNOWN
Kun Tuo Medical Research and Development (Beijing) Co. Ltd.
UNKNOWN
Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Wei Feng, Professor
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, China
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of XI'an Jiaotong University
Xi'an, Shaanxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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2024-14
Identifier Type: -
Identifier Source: org_study_id