Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation

Mitral Valve Regurgitation Clinical Trial

— ALIGN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01740583
• Other study ID #: CLPR-007
• Status: Active, not recruiting
• Phase: N/A
• First received: November 30, 2012
• Last updated: October 13, 2016
• Start date: November 2012
• Est. completion date: November 2017

Study information

• Verified date: October 2016
• Source: Mitralign, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Paraguay: Ministerio de Salud Pública y Bienestar Social
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: November 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• percutaneous annuloplasty
plication of the mitral valve annulus

Locations

Country	Name	City	State
Colombia	Clinica CardioVID	Medellin	Antioquia
Colombia	Antonio Dager, MD	Valle del Cauca	Cali
France	Bordeaux Heart University Hospital	Bordeaux-Pessac
France	Clinique Pasteur	Toulouse
Paraguay	Sanatorio Italiano	Asuncion
Poland	American Heart of Poland S.A.	Bielsko-Biala
Poland	Centrum Medyczne HZP	Poznan
Poland	Instytutem Kardiologii	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Mitralign, Inc.

Countries where clinical trial is conducted

Colombia,  France,  Paraguay,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Events (MAE)	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	within 30 days post procedure	Yes
Secondary	Echocardiographic Outcomes	Freedom from an increase in ventricular diameter	at 6 months	No