CG Future® Annuloplasty Ring/Band Clinical Trial

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.

Completed

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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

Interventional

Phase

Phase 4

Primary location

Cliniques Universitaires Saint Luc, Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

CG Future Annuloplasty Ring/Band

Device

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

Other names: Colvin Galloway Future Annuloplasty Ring, Colvin Galloway Future Annuloplasty Band, CG Future Annuloplasty Ring, CG Future Annuloplasty Band

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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Colvin-Galloway Future® Annuloplasty Ring/Band Clinical Trial: Interventional Multi-center Prospective Clinical Outcome Study

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Feb 24, 2010
Registry last updated: Oct 29, 2015

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