A prospective, global study designed to collect real-world clinical outcomes of the MITRIS RESILIA mitral valve - Europe (MOMENTIS)

Recruiting

Conditions: I34.0
Mitral (valve) insufficiency
Other mitral valve diseases
Mitral stenosis with insufficiency
I05.8
I05.2

Registration Number: DRKS00033584

Lead Sponsor: Edwards Lifesciences LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 120

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. Provides written informed consent
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*
3. Less than 2-year life expectancy due to non-cardiovascular life-threatening disease
4. High predicted risk of mortality prior to procedure
• STS PROM > 8 or
• Surgeon estimated risk of mortality of > 8
*eGFR < 30 is excluded

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Freedom from valve related death or valve related reintervention at 1 year as determined by the CEC<br>• Hemodynamic performance at 1 year as confirmed by echocardiography and ECL evaluation which will include the following parameters:<br>- Mean Gradient<br>- Peak gradient<br>- Transvalvular regurgitation and paravalvular leak, separately<br>

Secondary Outcome Measures

Name	Time	Method
• Linearized rates of major cardiac events summarizing early (= 30 days) and late (> 30 days) post-operative period inclusive of the follow events as determined by the CEC or ECL<br>- Thromboembolism (Stroke, TIA, Non-Cerebral)<br>- Valve thrombosis<br>- Paravalvular leak (> mild ‘2+’)<br>- Major bleeding<br>- Nonstructural valve dysfunction (NSVD)<br>- Structural valve deterioration (SVD)<br>- Endocarditis<br>- Valve related reintervention <br>- Death<br>• Functional improvement from baseline for NYHA Class (all follow-up time points) <br>• Improvement from baseline for quality of life as measured by SF-36v2 (all applicable follow-up time points)