Evaluating the MITRIS RESILIA Mitral Valve in Asian Patients
Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population(THE KOREA MITRIS REGISTRY)
This study is testing how safe and effective the MITRIS RESILIA mitral valve is for Asian patients who are having surgery to replace their mitral valve.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 1 site (Seoul, SONGPA-GU) |
| Trial ID | NCT06757049 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the early and mid-term safety and performance of the MITRIS RESILIA mitral valve in Asian patients undergoing mitral valve replacement surgery. It is a multicenter, prospective study that plans to enroll 200 patients across various institutions in South Korea. Participants will be followed for five years post-surgery, with assessments at multiple intervals to gather real-world clinical outcomes. The study seeks to provide valuable data on the effectiveness of this specific valve in the target population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 or older who require mitral valve replacement due to mitral valve dysfunction.
Not a fit: Patients with a life expectancy of less than one year from causes other than cardiovascular disease or those at high surgical risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the MITRIS RESILIA mitral valve's performance and safety in Asian patients, potentially leading to improved treatment options.
How similar studies have performed: While this study focuses on a specific population and device, similar observational studies have shown success in evaluating valve performance in diverse patient groups.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul, SONGPA-GU
- Asan Medical Center — Seoul, Songpa-Gu, South Korea (Recruiting)
Study contacts
- Study coordinator: Hojin Kim, Pi
- Email: rhonin.hojin@gmail.com
- Phone: 82-2-3010-0506
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.