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

Last updated: December 26, 2024
Sponsor: Asan Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mitral Valve Regurgitation

Treatment

N/A

Clinical Study ID

NCT06757049
2024-1268
  • Ages > 19
  • All Genders

Study 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

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 theIRB and agree to the research protocol and clinical follow-up schedule.

Exclusion

Exclusion Criteria:

  1. Life expectancy of less than one year due to causes other than cardiovasculardisease

  2. High-risk candidates for mitral valve replacement: Society of Thoracic SurgeonsPredicted Risk of Mortality 10% or greater; EuroSCORE 10% or greater; estimatedsurgical mortality rate by the surgeon 10% or greater

  3. Chronic kidney disease: eGFR <30 mL/min/1.73m²

  4. Undergoing surgery for infective endocarditis

Study Design

Total Participants: 200
Study Start date:
December 20, 2024
Estimated Completion Date:
March 31, 2031

Study Description

This study is a prospective, investigator-Investigator initiated, multicenter observational study that aims to competitively register 200 patients who have undergone mitral valve replacement surgery with the MITRIS RESILIA mitral valve at participating institutions to collect real clinical outcomes.

This study will collect data on clinical outcomes obtained during standard care for patients who undergo mitral valve replacement surgery using the MITRIS RESILIA mitral valve in South Korea.

The aim is to recruit 200 patients using the MITRIS RESILIA mitral valve (competitive recruitment, no more than 100 per institution) over a period of two years.

All patients registered in the registry will be followed for five years. Follow-up assessments will occur at 6 months, 1 year, 2 years, 3 years, and 5 years post-surgery. Including the 2-year registration period and 5 years of follow-up for result analysis, the total study duration is expected to be approximately 7.5 years. However, the overall duration may vary depending on the rate of participant registration.

Connect with a study center

  • Asan Medical Center

    Seoul, Songpa-gu
    Korea, Republic of

    Active - Recruiting

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