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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014