NCT06757049 Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population
| NCT ID | NCT06757049 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Asan Medical Center |
| Condition | Mitral Valve Insufficiency |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-12-20 |
| Primary Completion | 2031-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-12-20 with a primary completion date of 2031-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the early and mid-term safety and performance of the MITRIS RESILIA mitral valve in Asian patients in a real-world setting
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
Contact & Investigator
HOJIN KIM, PI
STUDY CHAIR
cadiovascularthoracic surgery
Frequently Asked Questions
Who can join the NCT06757049 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Mitral Valve Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06757049 currently recruiting?
Yes, NCT06757049 is actively recruiting participants. Contact the research team at rhonin.hojin@gmail.com for enrollment information.
Where is the NCT06757049 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06757049 clinical trial?
NCT06757049 is sponsored by Asan Medical Center. The principal investigator is HOJIN KIM, PI at cadiovascularthoracic surgery. The trial plans to enroll 200 participants.