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Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation — ALIGN  

Mitral Valve Regurgitation Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01740583
Study type Interventional
Source Mitralign, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date November 2012
Completion date November 2017
View Details
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