Overview

This trial is active, not recruiting.

Condition mitral valve insufficiency
Sponsor Medtronic Bakken Research Center
Start date February 2013
End date December 2016
Trial size 152 participants
Trial identifier NCT01112566, BRC-CS-2010-03

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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.

Additional Information

Official title EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Medtronic Cardiovascular.