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

This study is currently recruiting participants.
Verified March 2013 by Medtronic Bakken Research Center
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01112566
First received: April 27, 2010
Last updated: March 23, 2013
Last verified: March 2013

April 27, 2010
March 23, 2013
March 2013
March 2014   (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. [ Designated as safety issue: No ]
  • Assess the percentage of patients that are chronically relieved from mitral valve dysfunction [ Time Frame: 6-12 months follow up ] [ Designated as safety issue: No ]
  • Determine the level of mitral valve regurgitation in patients [ Time Frame: 6-12 months post-surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Leaflet coaptation [ Time Frame: Within 3 months prior to implantation and at 9 month follow-up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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 who get successfully implanted with, and benefit from the implantation of a Profile 3D annuloplasty ring in terms of chronic relief of 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.
 
Recruiting
150
May 2014
March 2014   (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.
Both
18 Years to 85 Years
No
Contact: Anneleen Daniels +31 43 356 6789 anneleen.daniels@medtronic.com
Contact: Bèr Kleijnen, MSc +31 43 356 6812 ber.kleijnen@medtronic.com
Germany
 
NCT01112566
BRC-CS-2010-03
No
Medtronic Bakken Research Center
Medtronic Bakken Research Center
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Medtronic Bakken Research Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP