Atrial Functional Mitral Regurgitation Response In Mitral Loop Cerclage Annuloplasty (AFRICA Study)

Study Overview
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Brief Summary
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To evaluate second stage 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 and Atrial Fibrillation mitral regurgitation Response in Mitral Loop Cerclage annuloplasty.

Official Title
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The Study for Atrial Functional Mitral Regurgitation Response In Mitral Loop Cerclage Annuloplasty (AFRICA Study): Multi-center, Open Label, Single Arm, Feasibility Test

Conditions
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Atrial 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, Functional Mitral Regurgitation 3+ (Moderate/Severe) or 4+ (Severe) 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) and, Chronic Atrial Fibrillation in electrocardiography (Persistent AF or Permanent AF) Exclusion Criteria: Primary Mitral Regurgitation LV ejection fraction lower than 30% Pulmonary arterial pressure ≥ 60mmHg End-diastolic Left ventricular dimension ≥ 70mm Subjects with functional MR who need CABG or AVR performed Pre-existing stent in a coronary artery that is deemed to be in direct contact with the path of mitral loop cerclage along coronary sinus 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 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 primary MR 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 do not have septal vein or have unsuitable septal vein anatomy by cardiac CT or venogram Subjects who have thrombosis and embolism Creatinine ≥2.0 mg/dL Subjects who have coagulation disorders Subjects who are unable to take anti-platelet agents Pre-existing devices such as Implantable Cardioverter Defibrillator and Pacemaker Subjects who are pregnant, or lactating, or plan pregnancy during the clinical trials Subjects who are participated in other clinical trials within 1 month of enrollment 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: Mitral Loop Cerclage<br>Intervention: Device: Mitral Loop Cerclage Annuloplasty with CSTV Protective Device | Device: Mitral Loop Cerclage Annuloplasty<br>* Atrial Functional mitral regurgitation Response In mitral loop Cerclage Annuloplasty<br>* Other names: (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(1) | changing regurgitant volume (RV,mL) compared with baseline | 1 month | 
| Change of mitral regurgitation severity(2) | changing effective regurgitant orifice (ERO,cm^2) compared with baseline | 1 month | 
| Change in mitral annulus geometry | septal lateral dimension(mm) | 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(1) | changing regurgitant volume (RV,mL) compared with baseline | 6 months | 
| Change of mitral regurgitation severity(2) | changing effective regurgitant orifice (ERO,cm^2) compared with baseline | 6 months | 
| Change in mitral annulus geometry | septal lateral dimension(mm) | 6 months | 
| Change in left ventricle volumes | Changing of End-diastolic phase LV volumes(mL) | 6 months | 
| Electrical remodeling | change in electrocardiography (conversion of atrial fibrillation to normal sinus rhythm) | 6 months | 
| Change in subjects' symptoms referred to NYHA Classification System | NYHA (New York Heart Association) | 6 months | 
| Technical success rate of the implantation | Technical feasibility by the implantation success rate (%) | 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, atrial fibrillation, Mitral Regurgitation