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

Recruiting

• Conditions: Mitral Valve Insufficiency

• Registration Number: NCT06757049
• Lead Sponsor: Asan Medical Center

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

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 Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-20
• Study First Submitted: 2024-12-26
• Study First Submitted QC: 2024-12-26
• Last Update Submitted: 2024-12-26
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03
• Primary Completion: 2031-03-31
• Study Completion: 2031-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of