CG Future® Annuloplasty Ring/Band Clinical Trial

Phase 4

Completed

• Conditions: Mitral Valve Insufficiency
• Interventions: Device: CG Future Annuloplasty Ring/Band

• 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

Arm && Interventions

Group	Intervention	Description
No control arm	CG Future Annuloplasty Ring/Band	There is no control arm as part of the study design.

Primary Outcome Measures

Name	Time	Method
The percentage of patients that are chronically relieved from mitral valve insufficiency	Within 3 months prior to implantation and at 9 month follow-up
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

Trial Locations

Locations (8)

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

Haukeland Universitetssykehus; 🇳🇴 Bergen, Norway

Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Belgium

UZ Gent; 🇧🇪 Gent, Belgium

Athens Medical Center; 🇬🇷 Athens, Greece

Virga Jesse Hospital; 🇧🇪 Hasselt, Belgium

Technische Universitat Dresden; 🇩🇪 Dresden, Germany

Albertinen Krankenhaus Hamburg; 🇩🇪 Hamburg, Germany