Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation

Overview

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

Full Title of Study: “A Feasibility Study of the Mitralign Annuloplasty System for the Treatment of Chronic Functional Mitral Valve Regurgitation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2017

Detailed Description

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.

Interventions

  • Device: percutaneous annuloplasty
    • plication of the mitral valve annulus

Arms, Groups and Cohorts

  • Experimental: annuloplasty
    • All patients will receive treatment with the Mitralign Percutaneous Annuloplasty System (MPAS).

Clinical Trial Outcome Measures

Primary Measures

  • Major Adverse Events (MAE)
    • Time Frame: within 30 days post procedure
    • 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

Secondary Measures

  • Echocardiographic Outcomes
    • Time Frame: at 6 months
    • Freedom from an increase in ventricular diameter

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mitralign, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Adrian Ebner, M.D., Principal Investigator, Sanatorio Italiano (The Italian Hospital)

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