Evaluating the MITRIS RESILIA Mitral Valve in Asian Patients
Official title: Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population(THE KOREA MITRIS REGISTRY)
Run by Asan Medical Center · NCT06757049 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 1 site (Seoul, SONGPA-GU) |
| Status | Recruiting |
| Started | December 20, 2024 |
| Main results expected | March 31, 2031 |
| Study ends | March 31, 2031 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT06757049 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 19 or older who require mitral valve replacement due to mitral valve dysfunction.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this study focuses on a specific population and device, similar observational studies have shown success in evaluating valve performance in diverse patient groups.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Korea VHD Echo Study: Real-World Practice of Aortic, Mitral, and Tricuspid Valves
This study looks at how valvular heart disease is managed in Korea by reviewing echocardiograms and medical records from multiple centers to see patterns in disease progression and treatment.
-
Investigating multiple and mixed heart valve diseases
This study looks at how common different types of heart valve diseases are and their features by gathering information from patients around the world who have been diagnosed with these conditions.
-
DragonFly EU Pivotal: Transcatheter mitral valve repair for mitral regurgitation
This trial tests the DragonFly transcatheter mitral valve repair system in adults with symptomatic moderate-to-severe or severe degenerative or functional mitral regurgitation who are high surgical risk or remain symptomatic after treatment.
-
Evaluating a new device for repairing the mitral valve
This study is testing a new device to see if it can safely help people with severe mitral valve problems who can't have regular surgery.
-
Observational registry for patients treated with the NeoChord Artificial Chordae System
This study is looking at how well the NeoChord Artificial Chordae System works for people with degenerative mitral valve disease over five years, without needing any extra procedures beyond regular treatment.
-
Evaluating imaging parameters in patients with mitral valve insufficiency due to prolapse
This study is testing how different imaging techniques can help doctors better understand and treat patients with mitral valve problems caused by prolapse.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.