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CG Future® Annuloplasty Ring/Band Clinical Trial

This study has been completed.
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center ) Identifier:
First received: January 26, 2010
Last updated: October 28, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Mitral Valve Insufficiency
Device: CG Future Annuloplasty Ring/Band
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Colvin-Galloway Future® Annuloplasty Ring/Band Clinical Trial: Interventional Multi-center Prospective Clinical Outcome Study

Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • 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 ]

Enrollment: 77
Study Start Date: June 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01074671

Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
UZ Gent
Gent, Belgium, 9000
Virga Jesse Hospital
Hasselt, Belgium, B-3500
Technische Universitat Dresden
Dresden, Germany, D-01307
Albertinen Krankenhaus Hamburg
Hamburg, Germany, 22457
Athens Medical Center
Athens, Greece, 15155
Haukeland Universitetssykehus
Bergen, Norway, N-5021
Szpital Wojewódzki Nr 2 w Rzeszowie
Rzeszów, Poland, 35-301
Sponsors and Collaborators
Medtronic Bakken Research Center
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
  More Information

Additional Information:
Responsible Party: Medtronic Bakken Research Center Identifier: NCT01074671     History of Changes
Other Study ID Numbers: BRC-CS-2009-06
Study First Received: January 26, 2010
Last Updated: October 28, 2015

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases processed this record on April 26, 2017