Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2017-11-30

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.

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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.

Conditions

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Mitral Valve Regurgitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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annuloplasty

All patients will receive treatment with the Mitralign Percutaneous Annuloplasty System (MPAS).

Group Type EXPERIMENTAL

percutaneous annuloplasty

Intervention Type DEVICE

plication of the mitral valve annulus

Interventions

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percutaneous annuloplasty

plication of the mitral valve annulus

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No