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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mitral Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

London Health Sciences Centre, University Hospital, London, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Time frame: screening
Assess the percentage of patients that are chronically relieved from mitral valve dysfunction

Time frame: 6-12 months follow up
Determine the level of mitral valve regurgitation in patients

Time frame: 6-12 months post-surgery

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2017
First posted: Apr 28, 2010
Registry last updated: Apr 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed