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
  Purpose

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.


Condition
Mitral Valve Insufficiency

Study Type: Observational
Study Design: 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

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: March 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112566

Contacts
Contact: Anneleen Daniels +31 43 356 6789 anneleen.daniels@medtronic.com
Contact: Bèr Kleijnen, MSc +31 43 356 6812 ber.kleijnen@medtronic.com

Locations
Germany
SANA Herzchirurgie Stuttgart GmbH Recruiting
Stuttgart, Germany, 70174
Principal Investigator: R Gunzinger, Dr. Med.         
Sponsors and Collaborators
Medtronic Bakken Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01112566     History of Changes
Other Study ID Numbers: BRC-CS-2010-03
Study First Received: April 27, 2010
Last Updated: March 23, 2013
Health Authority: Germany: Ethics Commission
United Kingdom: Research Ethics Committee
Czech Republic: Ethics Committee
Italy: Ethics Committee
France: Conseil National de l'Ordre des Médecins
France: Institutional Ethical Committee

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

ClinicalTrials.gov processed this record on April 16, 2014