Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

Launched by EDWARDS LIFESCIENCES · Aug 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the MITRIS RESILIA Mitral Valve, which is used to replace damaged mitral valves in people who have heart conditions like mitral stenosis or mitral valve insufficiency. The goal is to gather information on how safe and effective this valve is in real-life situations, both shortly after surgery and over a longer period. The trial is currently looking for participants who are at least 18 years old, have a dysfunctional mitral valve that needs to be replaced, and are willing to follow the study guidelines.

To be eligible, participants must not have certain serious health issues, such as a recent heart infection or severe kidney disease, and they should have a life expectancy of more than two years. Those who join the study can expect to receive the new valve and will be monitored closely to assess how well it works and to ensure their safety during the process. This trial is important because it aims to improve our understanding of this specific mitral valve’s performance in everyday clinical settings.

Gender

ALL

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
• • 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