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

Mitral Valve Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112566
• Other study ID #: BRC-CS-2010-03
• Status: Completed
• First received: April 27, 2010
• Last updated: April 25, 2018
• Start date: February 2013
• Est. completion date: May 2017

Study information

• Verified date: April 2018
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: May 2017
• Est. primary completion date: April 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mitral Valve Insufficiency

Locations

Country	Name	City	State
Canada	London Health Sciences Centre, University Hospital	London	Ontario
Czechia	Nemocnice Ceske Budejovice A.S.	Ceske Budejovice
France	Hôpital Haut - Leveque - CHU Pessac Cedex Bordeaux	Bordeaux
France	CHU de Nantes - Hôpital Nord Laennec	Nantes
Germany	Deutsches Herzzentrum München	München
Germany	SANA Herzchirurgie Stuttgart GmbH	Stuttgart
Italy	Azienda Ospedaliero Universitaria Careggi	Firenze

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Countries where clinical trial is conducted

Canada,  Czechia,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify the patient population for which a Profile 3D Annuloplasty Ring is chosen to repair the mitral valve insufficiency.		screening
Primary	Assess the percentage of patients that are chronically relieved from mitral valve dysfunction		6-12 months follow up
Primary	Determine the level of mitral valve regurgitation in patients		6-12 months post-surgery

External Links

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