CG Future® Annuloplasty Ring/Band Clinical Trial

Medtronic Cardiac Rhythm and Heart Failure77 enrolled

Overview

The primary goal of the study is to document the number of patients that are successfully implanted and benefit from the implantation of both a CG Future Annuloplasty ring or a band.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mitral Valve Insufficiency

Interventions

CG Future Annuloplasty Ring/BandDEVICE

A CG Future Annuloplasty Ring or Band will be implanted, following standard care

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed and dated the Patient Informed Consent (PIC); * Indicated to have a surgical repair for a given degree of moderate to severe mitral valve regurgitation; * Willing to return to the implanting hospital for a 9 month follow-up visit Exclusion Criteria: * Unwilling or inability to sign the PIC; * Already participating in another investigational device study, if this would create bias and jeopardize scientific appropriate assessment of the current study endpoints; * Life expectancy of less than one year; * Pregnant or desire to be pregnant within 12 months of the study treatment; * Less than 18 years and more than 85 years of age.

Locations (8)

Cliniques Universitaires Saint Luc

Brussels, Belgium

UZ Gent

Ghent, Belgium

Virga Jesse Hospital

Hasselt, Belgium

Technische Universitat Dresden

Dresden, Germany

Outcomes

Primary Outcomes

Identification of the patient population for which a CG Future Annuloplasty Ring or Band is chosen to repair the mitral valve insufficiency

Time frame: Within 3 months prior to implantation

The percentage of patients that are chronically relieved from mitral valve insufficiency

Time frame: Within 3 months prior to implantation and at 9 month follow-up

The level of mitral valve regurgitation

Time frame: Within 3 months prior to implantation and at 9 month follow-up

Data from ClinicalTrials.gov

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