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

Completed

• Conditions: Mitral Valve Insufficiency

• Registration Number: NCT01112566
• Lead Sponsor: Medtronic Bakken Research Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-27
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-28
• Study Start: 2013-02
• Primary Completion: 2017-04-26
• Study Completion: 2017-05
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-25
• Last Update Posted: 2018-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (7)

Hôpital Haut - Leveque - CHU Pessac Cedex Bordeaux; 🇫🇷 Bordeaux, France

Deutsches Herzzentrum München; 🇩🇪 München, Germany

London Health Sciences Centre, University Hospital; 🇨🇦 London, Ontario, Canada

Nemocnice Ceske Budejovice A.S.; 🇨🇿 Ceske Budejovice, Czechia

CHU de Nantes - Hôpital Nord Laennec; 🇫🇷 Nantes, France

SANA Herzchirurgie Stuttgart GmbH; 🇩🇪 Stuttgart, Germany

Azienda Ospedaliero Universitaria Careggi; 🇮🇹 Firenze, Italy