Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population (THE KOREA MITRIS REGISTRY)

What this Trial Is About

Researchers are evaluating the early and mid-term safety and performance of the MITRIS RESILIA mitral valve in Asian patients who need mitral valve replacement due to mitral valve dysfunction. This prospective, multicenter observational study aims to collect real-world clinical outcomes from 200 patients who have undergone mitral valve replacement surgery using this specific valve in South Korea. The study will help understand how well the valve works and its safety over time in this population. Patients who have had mitral valve replacement surgery with the MITRIS RESILIA valve will be enrolled from participating institutions, with no more than 100 patients per center. Data will be collected during regular care visits as part of standard treatment. The study plans to recruit patients over two years and will follow all participants for five years after their surgery. Follow-up visits will occur at 6 months, 1 year, 2 years, 3 years, and 5 years after surgery to monitor health and valve performance. Participants will be assessed through standard clinical follow-ups, which may include evaluations related to cardiovascular health and valve function. Researchers will track important outcomes such as cardiovascular death, valve-related interventions, and any issues with valve structure or function one year after surgery. The total study duration, including recruitment and follow-up, is expected to last about 7.5 years but may vary depending on how quickly patients are enrolled.

Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population