CG Future® Annuloplasty Ring/Band Clinical Trial

Phase 4

Completed

• Conditions: Mitral Valve Insufficiency

• Registration Number: NCT01074671
• Lead Sponsor: Medtronic Bakken Research Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-02-23
• Study First Posted: 2010-02-24
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-28
• Last Update Posted: 2015-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The level of mitral valve regurgitation	Within 3 months prior to implantation and at 9 month follow-up
Identification of the patient population for which a CG Future Annuloplasty Ring or Band is chosen to repair the mitral valve insufficiency	Within 3 months prior to implantation
The percentage of patients that are chronically relieved from mitral valve insufficiency	Within 3 months prior to implantation and at 9 month follow-up

Trial Locations

Locations (8)

Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Belgium

UZ Gent; 🇧🇪 Gent, Belgium

Virga Jesse Hospital; 🇧🇪 Hasselt, Belgium

Technische Universitat Dresden; 🇩🇪 Dresden, Germany

Albertinen Krankenhaus Hamburg; 🇩🇪 Hamburg, Germany

Athens Medical Center; 🇬🇷 Athens, Greece

Haukeland Universitetssykehus; 🇳🇴 Bergen, Norway

Szpital Wojewódzki Nr 2 w Rzeszowie; 🇵🇱 Rzeszów, Poland