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CG Future® Annuloplasty Ring/Band Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01074671
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )

Tracking Information
First Submitted Date  ICMJE January 26, 2010
First Posted Date  ICMJE February 24, 2010
Last Update Posted Date October 29, 2015
Study Start Date  ICMJE June 2009
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2010)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CG Future® Annuloplasty Ring/Band Clinical Trial
Official Title  ICMJE Colvin-Galloway Future® Annuloplasty Ring/Band Clinical Trial: Interventional Multi-center Prospective Clinical Outcome Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mitral Valve Insufficiency
Intervention  ICMJE 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
Study Arms  ICMJE No control arm
There is no control arm as part of the study design.
Intervention: Device: CG Future Annuloplasty Ring/Band
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2012)
77
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2010)
75
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Germany,   Greece,   Norway,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01074671
Other Study ID Numbers  ICMJE BRC-CS-2009-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Cardiovascular ( Medtronic Bakken Research Center )
Study Sponsor  ICMJE Medtronic Bakken Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Medtronic Cardiovascular
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP