EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty

April 25, 2018 updated by: Medtronic Bakken Research Center
The goal of the study is to identify the patients suffering from a mitral valve condition who benefit from the implantation of a Profile 3D annuloplasty ring in terms of acute and long-term relief of mitral valve regurgitation.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

152

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

  • Canada
    • Ontario
      • London, Ontario, Canada, ON N6G 2V4
        • London Health Sciences Centre, University Hospital
  • Czechia
      • Ceske Budejovice, Czechia, 37001
        • Nemocnice Ceske Budejovice a.s.
  • France
      • Bordeaux, France, 33604
        • Hôpital Haut - Leveque - CHU Pessac Cedex Bordeaux
      • Nantes, France, 44800
        • CHU de Nantes - Hôpital Nord Laennec
  • Germany
      • München, Germany, 80636
        • Deutsches Herzzentrum München
      • Stuttgart, Germany, 70174
        • SANA Herzchirurgie Stuttgart GmbH
  • Italy
      • Firenze, Italy, 50134
        • Azienda Ospedaliero Universitaria Careggi

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 to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patient population includes all patients suffering from mitral valve disease, indicated for a mitral valve repair procedure, either as a stand-alone procedure or concomitant to a coronary artery bypass grafting, an aortic replacement or tricuspid valve repair and/or the treatment of atrial fibrillation, and for which the surgeon considers the implantation of a Profile 3D annuloplasty product most appropriate to reconstruct the regurgitant valve.

Description

Inclusion Criteria:

  • Indicated for a surgical repair for moderate to severe mitral valve regurgitation at rest (level 2 or higher);
  • Willing to return to the hospital where the implantation originally occurred as part of the standard practice of care

Exclusion Criteria:

  • Heavily calcified valves
  • Valvular retraction with severely reduced mobility
  • Active bacterial endocarditis
  • Already participating in another investigational device study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints;
  • Life expectancy of less than one year;
  • Pregnant or desire to be pregnant within 12 months of the study treatment;
  • Under 18 years or over 85 years of age.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identify the patient population for which a Profile 3D Annuloplasty Ring is chosen to repair the mitral valve insufficiency.
Time Frame: screening
screening
Assess the percentage of patients that are chronically relieved from mitral valve dysfunction
Time Frame: 6-12 months follow up
6-12 months follow up
Determine the level of mitral valve regurgitation in patients
Time Frame: 6-12 months post-surgery
6-12 months post-surgery

Collaborators and Investigators

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

Sponsor

Medtronic Bakken Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

February 1, 2013

Primary Completion (ACTUAL)

April 26, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

April 27, 2010

First Submitted That Met QC Criteria

April 27, 2010

First Posted (ESTIMATE)

April 28, 2010

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRC-CS-2010-03

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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