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

Launched by ASAN MEDICAL CENTER · Dec 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a new type of mitral valve called the MITRIS RESILIA in Asian patients who need replacement due to mitral valve insufficiency, which means their heart valve is not working properly. The goal is to see how well this valve performs over time in a real-world setting. The study is currently looking for participants aged 19 and older who require this type of surgery and can provide permission to take part in the trial.

To be eligible for the study, participants should not have serious health issues that would significantly lower their life expectancy or put them at high risk during the surgery. If someone joins the trial, they can expect to undergo the surgery and participate in follow-up appointments to monitor their recovery and the valve's performance. This study aims to ensure that the new valve is a safe and effective option for those in need.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 19 or older
• • 2. Requires mitral valve replacement due to mitral valve dysfunction
• • 3. The participant or their guardian can provide a written consent form approved by the IRB and agree to the research protocol and clinical follow-up schedule.
• Exclusion Criteria:
• • 1. Life expectancy of less than one year due to causes other than cardiovascular disease
• • 2. High-risk candidates for mitral valve replacement: Society of Thoracic Surgeons Predicted Risk of Mortality 10% or greater; EuroSCORE 10% or greater; estimated surgical mortality rate by the surgeon 10% or greater
• • 3. Chronic kidney disease: eGFR \<30 mL/min/1.73m²
• • 4. Undergoing surgery for infective endocarditis