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

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ClinicalTrials.gov Identifier: NCT01112566
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Mitral Valve Insufficiency

Study Design

Study Type : Observational
Actual Enrollment : 152 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty
Study Start Date : February 2013
Primary Completion Date : April 26, 2017
Study Completion Date : May 2017
Groups and Cohorts


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112566


Locations
Canada, Ontario
London Health Sciences Centre, University Hospital
London, Ontario, Canada, ON N6G 2V4
Czechia
Nemocnice Ceske Budejovice A.S.
Ceske Budejovice, Czechia, 37001
France
Hôpital Haut - Leveque - CHU Pessac Cedex Bordeaux
Bordeaux, France, 33604
CHU de Nantes - Hôpital Nord Laennec
Nantes, France, 44800
Germany
Deutsches Herzzentrum München
München, Germany, 80636
SANA Herzchirurgie Stuttgart GmbH
Stuttgart, Germany, 70174
Italy
Azienda Ospedaliero Universitaria Careggi
Firenze, Italy, 50134
Sponsors and Collaborators
Medtronic Bakken Research Center
More Information

Additional Information:
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01112566     History of Changes
Other Study ID Numbers: BRC-CS-2010-03
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases