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MITRIS China Post Market Clinical Follow-up (PMCF) Study | Clinical Trials | Clareo Health

RECRUITING

MITRIS China Post Market Clinical Follow-up (PMCF) Study

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

NCT07059793•Edwards Lifesciences

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (13)

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

Key Dates

Start Date

July 8, 2025

Primary Completion Date

December 1, 2028

Completion Date

December 1, 2038

Last Updated

December 30, 2025

Enrollment

250

ESTIMATED participants

Conditions

Mitral Valve Replacement

Interventions

MITRIS RESILIA Mitral Valve

DEVICE

Contacts

Honglei Sun

CONTACT

+8610 5641 0883 Honglei_Sun@edwards.com

WeiDavid Zhang

CONTACT

+86 010 56410915 WeiDavid_Zhang@edwards.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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