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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
ClinicalTrials.gov Identifier:
NCT01112566
First received: April 27, 2010
Last updated: August 10, 2015
Last verified: August 2015
  Purpose

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
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 Cardiovascular:

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: February 2013
Estimated Study Completion Date: October 2015
Primary Completion Date: July 2015 (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

Locations
Canada
London Health Sciences Centre, University Hospital
London Ontario, Canada, ON N6G 2V4
Czech Republic
Nemocnice Ceske Budejovice A.S.
Ceske Budejovice, Czech Republic, 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
Saudi Arabia
King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia, 12713
Sponsors and Collaborators
Medtronic Bakken Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Medtronic Cardiovascular ( 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: August 10, 2015
Health Authority: Germany: Institutional Ethics Commission
Czech Republic: Institutional Ethics Committee
Italy: Institutional Ethics Committee
France: Conseil National de l'Ordre des Médecins
France: Institutional Ethical Committee
Canada: Institutional Review Ethics Board
Saudi Arabia: Institutional Ethics Committee

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

ClinicalTrials.gov processed this record on August 30, 2015