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CompletedNCT01112566Updated Apr 26, 2018

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

An observational study in Mitral Valve Insufficiency, sponsored by Medtronic Bakken Research Center. Completed at 7 sites in 5 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-04-26.

Sponsored by Medtronic Bakken Research Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
152
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Mitral Valve Insufficiency
03

In context

Mitral Valve Insufficiency

459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.

This study's enrollment of 152 is close to the median of 154 across 167 observational studies indexed under Mitral Valve Insufficiency.

Browse Mitral Valve Insufficiency studies →

Lead sponsor

Medtronic Bakken Research Center is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
152 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  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

07

Study locations

7 sites
  • London Health Sciences Centre, University Hospital
    London, Ontario ON N6G 2V4, Canada
  • Nemocnice Ceske Budejovice A.S.
    Ceske Budejovice, 37001, Czechia
  • Hôpital Haut - Leveque - CHU Pessac Cedex Bordeaux
    Bordeaux, 33604, France
  • CHU de Nantes - Hôpital Nord Laennec
    Nantes, 44800, France
  • Deutsches Herzzentrum München
    München, 80636, Germany
  • SANA Herzchirurgie Stuttgart GmbH
    Stuttgart, 70174, Germany
  • Azienda Ospedaliero Universitaria Careggi
    Firenze, 50134, Italy
08

References and documents

Publications

  • Doll N, Sheytanov V, Labrousse L, Chu MWA, Stefano P, Mokracek A, Baron O, Li S, Gunzinger R. Clinical performance of a three-dimensional saddle-shaped, rigid ring for mitral valve repair. Eur J Cardiothorac Surg. 2019 Feb 1;55(2):217-223. doi: 10.1093/ejcts/ezy215. PubMed 29931248 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01112566
Lead sponsor
Medtronic Bakken Research Center
Responsible party
Sponsor
First posted
Apr 28, 2010
Start date
Feb 2013
Primary completion
Apr 26, 2017
Completion
May 2017
Last update
Apr 26, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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