Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

ID#: NCT05526560

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: January 11, 2023

End Date: December 01, 2035

Contact Information:
Kelly Hendrickson
949-250-2500
Sabrina Hundt, PhD
+49 (0)151 67550601
Summary: Collect real-world data 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:

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

- Provides written informed consent

- Willingness to follow protocol requirements

Exclusion Criteria:

- Active endocarditis 3 months prior to the procedure

- Stage 4 renal disease or requiring dialysis

- Less than 2-year life expectancy due to non-cardiovascular life-threatening disease

- High predicted risk of mortality prior to procedure

- Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) score of > 8 or

- Surgeon estimated risk of mortality of > 8
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