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

Medtronic

Status: Completed

Conditions: Mitral Valve Insufficiency

Study type: Observational

Funder types: Industry

Identifiers

NCT01112566

BRC-CS-2010-03

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.