Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation

Not Applicable

• Conditions: Mitral Valve Regurgitation
• Interventions: Device: percutaneous annuloplasty

• Registration Number: NCT01740583
• Lead Sponsor: Mitralign, Inc.

Brief 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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-30
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-17
• Primary Completion: 2017-01
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
annuloplasty	percutaneous annuloplasty	All patients will receive treatment with the Mitralign Percutaneous Annuloplasty System (MPAS).

Primary Outcome Measures

Name	Time	Method
Major Adverse Events (MAE)	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 Outcome Measures

Name	Time	Method
Echocardiographic Outcomes	at 6 months	Freedom from an increase in ventricular diameter

Trial Locations

Locations (8)

Bordeaux Heart University Hospital; 🇫🇷 Bordeaux-Pessac, France

Antonio Dager, MD; 🇨🇴 Valle del Cauca, Cali, Colombia

Instytutem Kardiologii; 🇵🇱 Warsaw, Poland

Centrum Medyczne HZP; 🇵🇱 Poznan, Poland

Clinica CardioVID; 🇨🇴 Medellin, Antioquia, Colombia

Sanatorio Italiano; 🇵🇾 Asuncion, Paraguay

Clinique Pasteur; 🇫🇷 Toulouse, France

American Heart of Poland S.A.; 🇵🇱 Bielsko-Biala, Poland