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Recruiting NCT07059793

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

— Observational Mitral Valve Replacement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MITRIS RESILIA Mitral Valve.
Who it may be relevant to
Registry conditions: Mitral Valve Replacement. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device MITRIS RESILIA Mitral Valve
    Surgical replacement of native or prosthetic mitral valve.

Primary outcome measures

  • Primary Safety outcome - Kaplan Meier (KM) rate of valve related death or reintervention [Time frame: 1 year]
  • Primary Performance outcome - Hemodynamics by echocardiography - Subject's Average Mean Gradient Measurements [Time frame: 1 year]
  • Primary Performance outcome - Hemodynamics by echocardiography - Subject's Average Peak Gradients Measurements [Time frame: 1 year]
  • Primary Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Transvalvular regurgitation [Time frame: 1 year]
  • Primary Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Paravalvular leak [Time frame: 1 year]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 13 centers
  • Beijing Anzhen Hospital, Capital Medical University — Beijing
  • Fuwai Hospital, CAMS & PUMC — Beijing
  • Xiamen Cardiovascular Hospital Xiamen University — Xiamen
  • Guangdong Provincial People's Hospital — Guangzhou
  • The First Affiliated Hospital of Zhengzhou University — Zhengzhou
  • Fuwai Central China Cardiovascular Hospital — Zhengzhou
  • Wuhan Asia Heart Hospital — Wuhan
  • Nanjing Drum Tower Hospital — Nanjing
  • … and 5 more centers

Identifiers

NCT: NCT07059793 · 2024-14

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗