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

NCT01112566 | Completed

• 1 other identifier: BRC-CS-2010-03
• Study Type: observational
• Target: 152
• Locations: 5 countries
• Sites: 7

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.

Conditions

Mitral Valve Insufficiency

Outcome Measures

Primary Outcomes (3)

• Identify the patient population for which a Profile 3D Annuloplasty Ring is chosen to repair the mitral valve insufficiency.

  screening

• Assess the percentage of patients that are chronically relieved from mitral valve dysfunction

  6-12 months follow up

• Determine the level of mitral valve regurgitation in patients

  6-12 months post-surgery

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (7)

London Health Sciences Centre, University Hospital

London, Ontario, ON N6G 2V4, Canada

Location

Nemocnice Ceske Budejovice A.S.

České Budějovice, 37001, Czechia

Location

Hôpital Haut - Leveque - CHU Pessac Cedex Bordeaux

Bordeaux, 33604, France

Location

CHU de Nantes - Hôpital Nord Laennec

Nantes, 44800, France

Location

Deutsches Herzzentrum München

München, 80636, Germany

Location

SANA Herzchirurgie Stuttgart GmbH

Stuttgart, 70174, Germany

Location

Azienda Ospedaliero Universitaria Careggi

Florence, 50134, Italy

Location

Related Publications (1)

• 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.

  PMID: 29931248 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: April 28, 2010
• Study Start: February 1, 2013
• Primary Completion: April 26, 2017
• Study Completion: May 1, 2017
• Last Updated: April 26, 2018

Record last verified: 2018-04

Locations

FR (2); CA (1); IT (1); DE (2); CZ (1)