CG Future® Annuloplasty Ring/Band Clinical Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01074671
First received: January 26, 2010
Last updated: January 27, 2012
Last verified: January 2012
  Purpose

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: Endpoint Classification: Efficacy Study
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 Bakken Research Center:

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The level of mitral valve regurgitation [ Time Frame: Within 3 months prior to implantation and at 9 month follow-up ] [ Designated as safety issue: No ]

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)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074671

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

Additional Information:
No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01074671     History of Changes
Other Study ID Numbers: BRC-CS-2009-06
Study First Received: January 26, 2010
Last Updated: January 27, 2012
Health Authority: Greece: Ethics Committee
Belgium: Institutional Review Board
Poland: Ethics Committee

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014