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CG Future® Annuloplasty Ring/Band Clinical Trial

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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 )

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Colvin-Galloway Future® Annuloplasty Ring/Band Clinical Trial: Interventional Multi-center Prospective Clinical Outcome Study
Study Start Date : June 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. The level of mitral valve regurgitation [ Time Frame: Within 3 months prior to implantation and at 9 month follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074671


Locations
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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
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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
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Additional Information:

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Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01074671    
Other Study ID Numbers: BRC-CS-2009-06
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases