MITRIS China Post Market Clinical Follow-up (PMCF) Study
ConditionMitral Valve Replacement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEdwards Lifesciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MITRIS RESILIA Mitral Valve
DeviceSurgical replacement of native or prosthetic mitral valve.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: MITRIS RESILIA Mitral Valve1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1 year2
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.
Time frame
1 year3
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.
Time frame
1 year4
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.
Time frame
1 yearSecondary outcomes
1
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.
Time frame
10 years2
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.
Time frame
10 years3
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.
Time frame
10 years4
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.
Time frame
10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Edwards Lifesciences
Lead sponsor
Edwards (Shanghai) Medical Products Co. Ltd.
Collaborator
Kun Tuo Medical Research and Development (Beijing) Co. Ltd.
Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator
Source ClinicalTrials.gov