Overview

This trial is active, not recruiting.

Condition mitral valve regurgitation
Treatment percutaneous annuloplasty
Sponsor Mitralign, Inc.
Start date November 2012
End date January 2017
Trial size 50 participants
Trial identifier NCT01740583, CLPR-007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
All patients will receive treatment with the Mitralign Percutaneous Annuloplasty System (MPAS).
percutaneous annuloplasty
plication of the mitral valve annulus

Primary Outcomes

Measure
Major Adverse Events (MAE)
time frame: within 30 days post procedure

Secondary Outcomes

Measure
Echocardiographic Outcomes
time frame: at 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Feasibility Study of the Mitralign Annuloplasty System for the Treatment of Chronic Functional Mitral Valve Regurgitation
Principal investigator Adrian Ebner, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Mitralign, Inc..