Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation (ALIGN)

October 13, 2016 updated by: Mitralign, Inc.

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

The purpose of this study is to test the safety and device performance of the Mitralign system ("MPAS") to treat functional mitral valve regurgitation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Clinica CardioVID
    • Cali
      • Valle del Cauca, Cali, Colombia
        • Antonio Dager, MD
  • France
      • Bordeaux-Pessac, France, 33604
        • Bordeaux Heart University Hospital
      • Toulouse, France, 31076
        • Clinique Pasteur
  • Paraguay
      • Asuncion, Paraguay
        • Sanatorio Italiano
  • Poland
      • Bielsko-Biala, Poland, 43-316
        • American Heart of Poland S.A.
      • Poznan, Poland, 61-485
        • Centrum Medyczne HZP
      • Warsaw, Poland, 04-628
        • Instytutem Kardiologii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: annuloplasty
All patients will receive treatment with the Mitralign Percutaneous Annuloplasty System (MPAS).
Device: percutaneous annuloplasty
plication of the mitral valve annulus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Events (MAE)
Time Frame: 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
within 30 days post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Echocardiographic Outcomes
Time Frame: at 6 months
Freedom from an increase in ventricular diameter
at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitralign, Inc.

Investigators

  • Principal Investigator: Adrian Ebner, M.D., Sanatorio Italiano (The Italian Hospital)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

November 30, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Estimate)

October 17, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLPR-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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