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

Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population(THE KOREA MITRIS REGISTRY)

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

Study Overview

• Status: Recruiting
• Conditions: Mitral Valve Insufficiency

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: HOJIN KIM, PI; Phone Number: 82-2-3010-0506; Email: rhonin.hojin@gmail.com
• Study Contact Backup: Name: YUKYUNG CHOI, CRA; Phone Number: 82-2-2045-3815; Email: cyk1108@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of
      • Recruiting
      • Asan Medical Center
      • Contact: HOJIN KIM, PI; Phone Number: 82-2-3010-0506

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Asian(REPUBLIC OF KOREA)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular death	death that results from a disease of the heart or blood vessels	1 year post-surgery
Valve-related intervention	a procedure to repair or replace a diseased or faulty heart valve	1 year post-surgery
Structural valve deterioration and non-structural valve dysfunction	abnormality that's not intrinsic to the valve	1 year post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak and mean trans-mitral valve pressure gradient and effective orifice area	echocardiographic parameters used to assess mitral valve disease	6 month,1 year,2 year,3 year, 5year post-surgery
All-cause death	the total number of deaths from any cause in a given population over a specific period of time	6 month,1 year,2 year,3 year, 5year post-surgery
cardiovascular death	a death that results from a disease of the heart or blood vessels	6 month,1 year,2 year,3 year, 5year post-surgery
Valve-related death	any death that is caused by Structural valve deterioration,Nonstructural dysfunction,Valve thrombosis,Embolism,Bleeding event,Operated valve endocarditis,Death related to reintervention on the operated valve	6 month,1 year,2 year,3 year, 5year post-surgery
Stroke (ischemic or hemorrhagic)	a medical emergency that occurs when blood flow to the brain is blocked or a blood vessel in the brain bursts	6 month,1 year,2 year,3 year, 5year post-surgery
Hospitalization due to cardiovascular disease	a hospital admission with a defined cardiovascular cause	6 month,1 year,2 year,3 year, 5year post-surgery
Bleeding	BARC classification use.(A standardized tool for defining and categorizing bleeding events in clinical trials.)	6 month,1 year,2 year,3 year, 5year post-surgery
Infective endocarditis related to the mitral valve	a bacterial, viral, or fungal infection of the mitral valve leaflets	6 month,1 year,2 year,3 year, 5year post-surgery
Valve-related reintervention	any invasive procedure performed on the aortic valve, coronary button, or proximal aorta	6 month,1 year,2 year,3 year, 5year post-surgery
Structural valve deterioration or non-structural valve dysfunction	a type of valve dysfunction that involves permanent damage to the valve	6 month,1 year,2 year,3 year, 5year post-surgery
Valve thrombosis	a rare but life-threatening condition that occurs when a thrombus forms on a prosthetic heart valve and interferes with blood flow or valve function	6 month,1 year,2 year,3 year, 5year post-surgery

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Edwards Lifesciences
• Investigators: Study Chair: HOJIN KIM, PI, cadiovascularthoracic surgery

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2031

Study Registration Dates

• First Submitted: December 26, 2024
• First Submitted That Met QC Criteria: December 26, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Mitral Valve Replacement
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 2024-1268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No