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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
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 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
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on November 27, 2014