Clinical trial NCT01112566: EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty
Official title: EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Valve Insufficiency
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2010-04-28
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Identify the patient population for which a Profile 3D Annuloplasty Ring is chosen to repair the mitral valve insufficiency.
timeFrame: screening
measure: Assess the percentage of patients that are chronically relieved from mitral valve dysfunction
timeFrame: 6-12 months follow up
measure: Determine the level of mitral valve regurgitation in patients
timeFrame: 6-12 months post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre, University Hospital
state: Ontario
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice A.S.
city: Bordeaux
country: France
facility: Hôpital Haut - Leveque - CHU Pessac Cedex Bordeaux
city: Nantes
country: France
facility: CHU de Nantes - Hôpital Nord Laennec
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: Stuttgart
country: Germany
facility: SANA Herzchirurgie Stuttgart GmbH
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
Study officials:
References:
citation: 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.