EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty
This trial is active, not recruiting.
|Condition||mitral valve insufficiency|
|Sponsor||Medtronic Bakken Research Center|
|Start date||February 2013|
|End date||November 2016|
|Trial size||152 participants|
|Trial identifier||NCT01112566, BRC-CS-2010-03|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|London Ontario, Canada||London Health Sciences Centre, University Hospital||no longer recruiting|
|Ceske Budejovice, Czech Republic||Nemocnice Ceske Budejovice A.S.||no longer recruiting|
|Bordeaux, France||Hôpital Haut - Leveque - CHU Pessac Cedex Bordeaux||no longer recruiting|
|Nantes, France||CHU de Nantes - Hôpital Nord Laennec||no longer recruiting|
|München, Germany||Deutsches Herzzentrum München||no longer recruiting|
|Stuttgart, Germany||SANA Herzchirurgie Stuttgart GmbH||no longer recruiting|
|Firenze, Italy||Azienda Ospedaliero Universitaria Careggi||no longer recruiting|
Identify the patient population for which a Profile 3D Annuloplasty Ring is chosen to repair the mitral valve insufficiency.
time frame: screening
Assess the percentage of patients that are chronically relieved from mitral valve dysfunction
time frame: 6-12 months follow up
Determine the level of mitral valve regurgitation in patients
time frame: 6-12 months post-surgery
All participants from 18 years up to 85 years old.
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.
|Official title||EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty|
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