CG Future® Annuloplasty Ring/Band Clinical Trial

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

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 Overview

• Status: Completed
• Conditions: Mitral Valve Insufficiency
• Intervention / Treatment: Device: CG Future Annuloplasty Ring/Band

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint Luc
  • Gent, Belgium, 9000
    • UZ Gent
  • Hasselt, Belgium, B-3500
    • Virga Jesse Hospital
• Germany
  • Dresden, Germany, D-01307
    • Technische Universität Dresden
  • Hamburg, Germany, 22457
    • Albertinen Krankenhaus Hamburg
• Greece
  • Athens, Greece, 15155
    • Athens Medical Center
• Norway
  • Bergen, Norway, N-5021
    • Haukeland Universitetssykehus
• Poland
  • Rzeszów, Poland, 35-301
    • Szpital Wojewodzki nr 2 w Rzeszowie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: No control arm; There is no control arm as part of the study design.	Device: CG Future Annuloplasty Ring/Band; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
The level of mitral valve regurgitation	Within 3 months prior to implantation and at 9 month follow-up

Collaborators and Investigators

• Sponsor: Medtronic Bakken Research Center
• Investigators: Principal Investigator: D C Iliopoulos, Prof, Athens Medical Center, Greece; Principal Investigator: M Hendrikx, Dr, Virga Jesse Hospital, Hasselt, Belgium; Principal Investigator: K François, Dr, UZ Gent, Belgium; Principal Investigator: G El Khoury, Dr, Cliniques Universitaires Saint Luc, Brussels, Belgium; Principal Investigator: K Widenka, Dr, Szpital Wojewódzki Nr 2 w Rzeszowie, Poland; Principal Investigator: R. Haaverstad, Prof., Haukeland Universitetssykehus, Bergen, Norway; Principal Investigator: K Matschke, Dr., Technische Universitat Dresden, Germany; Principal Investigator: F Riess, Dr., Albertinen Krankenhaus Hamburg, Germany

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: January 26, 2010
• First Submitted That Met QC Criteria: February 23, 2010
• First Posted (Estimate): February 24, 2010

Study Record Updates

• Last Update Posted (Estimate): October 29, 2015
• Last Update Submitted That Met QC Criteria: October 28, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: BRC-CS-2009-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No