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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01112566
First Posted: April 28, 2010
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
April 27, 2010
April 28, 2010
November 1, 2017
February 2013
April 26, 2017   (Final data collection date for primary outcome measure)
  • 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 ]
  • Identification of the patient population for which a Profile 3D annuloplasty ring is used for the surgical repair of a regurgitant mitral valve. [ Time Frame: Within 3 months prior to implantation ]
  • Reduction of insufficiency of the repaired mitral valve, both in terms of classification of dysfunction and level of regurgitation. [ Time Frame: Within 3 months prior to implantation and at 9 month follow-up ]
  • Leaflet coaptation [ Time Frame: Within 3 months prior to implantation and at 9 month follow-up ]
Complete list of historical versions of study NCT01112566 on ClinicalTrials.gov Archive Site
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EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty
EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty
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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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
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.
Mitral Valve Insufficiency
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
152
May 2017
April 26, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Czechia,   France,   Germany,   Italy
Belgium,   Czech Republic,   Saudi Arabia,   United Kingdom
 
NCT01112566
BRC-CS-2010-03
No
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Medtronic Cardiovascular ( Medtronic Bakken Research Center )
Medtronic Bakken Research Center
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Medtronic Cardiovascular
October 2017