NCT01740583

Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Mitralign, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Mitral Valve Regurgitation

Interventions

Type	Name	Description
DEVICE	percutaneous annuloplasty	plication of the mitral valve annulus

Timeline

• Start date: 2012-11-01
• Primary completion: 2017-01-01
• Completion: 2017-11-01
• First posted: 2012-12-04
• Last updated: 2016-10-17

Locations

8 sites across 4 countries: Colombia, France, Paraguay, Poland