EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty
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ClinicalTrials.gov Identifier: NCT01112566
: April 28, 2010
Last Update Posted
: November 1, 2017
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Cardiovascular ( 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.
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Ages Eligible for Study:
18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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
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;