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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01740583

Acronym

ALIGN

Enrollment

Registered

2012-12-04

Start date

2012-11-30

Completion date

2017-11-30

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Regurgitation

Keywords

mitral valve, regurgitation, annuloplasty

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.

Interventions

DEVICEpercutaneous annuloplasty

plication of the mitral valve annulus

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Echocardiographic Outcomes	at 6 months	Freedom from an increase in ventricular diameter

Countries

Colombia, France, Paraguay, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026