Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation

Study Overview
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Brief Summary
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To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.

Detailed Description
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The objective of this prospective, single-center, open label, feasibility test is to assess the safety and efficacy of Mitral Loop Cerclage Annuloplasty with CSTV protective device in treating functional mitral regurgitation (FMR) associated with heart failure.

Official Title
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The Study on Safety and Feasibility of Mitral Loop Cerclage(MLC) Annuloplasty Procedure With Investigational Medical Device (MLC-B-45-75-R and Other 11 Models) : Single-centre, Open Label, Single Arm, Feasibility Test

Conditions
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Functional Mitral Regurgitation, Heart Failure

Intervention / Treatment
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* Device: Mitral Loop Cerclage Annuloplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NYHA(New York Heart Association) Class III - IV, and symptomatic severe functional MR by 2014 ACC/AHA guideline in spite of optimal medical treatment. (For optimal medical treatments, ①ACE inhibitor or angiotensin receptor blocker ②β-blocker ③ aldosterone antagonists should be given for at least 3 months unless the subject has contraindication for each drug) Exclusion Criteria: Primary Mitral Regurgitation LV ejection fraction lower than 25% Creatinine ≥2.0 mg/dL Anomaly of Coronary Sinus Pre-existing devices in coronary sinus such as Implantable Cardioverter Defibrillator and Pacemaker 2:1 Atriventricular AV block or higher AV block and ventricular tachycardia Subjects with functional MR who need CABG or AVR performed Subjects who have functional MR caused by aortic valve disease Subjects who have uncontrollable hyperthyroidism Subjects who have severe TR due to primary valve leaflet disease Subjects who cannot be screened by cardiac CT Subjects who have possibility of coronary artery pinching even with Mitral Loop Cerclage system judged by cardiac CT Subjects who are unable to take anti-platelet agents Subjects who are participated in other clinical trials within 1 month of enrollment Subjects who have coagulation disorders Subjects who have thrombosis and embolism Subjects who are pregnant, or lactating, or plan pregnancy during the clinical trials Subjects who are deemed not to be eligible in this study by physician's discretion

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single<br>Intervention: Device: Mitral Loop Cerclage Annuloplasty with CSTV Protective Device | Device: Mitral Loop Cerclage Annuloplasty<br> <br> * Other names: MLC series (MLC-B-45-75-R and other 11 models);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO) |  | 1 month | 
| Change in mitral annulus geometry (septal lateral dimension) |  | 1 month | 
| Rate of adverse events as a measure of safety | Rate of composite endpoint of MACE (Major Adverse Cardiac Event) * Death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO) |  | 6 months | 
| Change in mitral annulus geometry (septal lateral dimension) |  | 6 months | 
| Change in mitral valve hemodynamics |  | 6 months | 
| Change in left ventricle volumes |  | 6 months | 
| Change in subjects' symptoms referred to NYHA (New York Heart Association) Classification System |  | 6 months | 
| Technical success rate of the implantation and technical feasibility |  | 6 months | 
| Rate of adverse events as a measure of safety | Rate of composite endpoint of MACE (Major Adverse Cardiac Event) * Death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous mitral valve repair, Coronary sinus annuloplasty, Mitral loop cerclage