Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation

Study Overview
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Brief Summary
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The purpose of this study is to test the safety and device performance of the Mitralign system (MPAS) to treat functional mitral valve regurgitation.

Detailed Description
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The ALIGN study is a single arm, prospective study. The objective of the study is to investigate the safety and performance of a catheter-based plication device intended to reduce the circumference of the dilated mitral valve. The study will enroll up to 50 subjects from up to 5 sites (Paraguay, Columbia, Dominican Republic, Brazil, and India) who will be followed for 36 months post index procedure. Enrollment is defined at the time the study device is inserted into the body and patients will be followed at 30 days, and Months 6, 12, 24 and 36 post index procedure.

Official Title
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A Feasibility Study of the Mitralign Annuloplasty System for the Treatment of Chronic Functional Mitral Valve Regurgitation

Conditions
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Mitral Valve Regurgitation

Intervention / Treatment
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* Device: percutaneous annuloplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NYHA II-IV Structurally normal mitral valve At least Grade 2 mitral regurgitation Left ventricular ejection fraction not less than 20% and not greater than 45% Left ventricular end diastolic diameter not less than 5.0 cm and not greater than 7.5 cm Exclusion Criteria: Pregnant or lactating female Mitral stenosis Mod/severe aortic stenosis or regurgitation Mod/severe tricuspid stenosis or regurgitation Endocarditis Previous mitral valve repair or MV replacement Bioprosthetic or mechanical aortic valve Known unstable angina or MI within 30 days prior to procedure CVA within past 6 months Known contraindications to blood transfusion, contrast dye, DAPT

Ages Eligible for Study
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Minimum Age: 18 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: annuloplasty<br>All patients will receive treatment with the Mitralign Percutaneous Annuloplasty System (MPAS). | Device: percutaneous annuloplasty<br>* plication of the mitral valve annulus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events (MAE) | MAE defined as occurrence of any of the following: Mitral valve-related surgery/intervention, myocardial infarction, cardiac tamponade, stroke, device and/or procedure-related death | within 30 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiographic Outcomes | Freedom from an increase in ventricular diameter | at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mitral valve, regurgitation, annuloplasty