CG Future® Annuloplasty Ring/Band Clinical Trial

• ClinicalTrials.gov Identifier: NCT01074671
• Recruitment Status: Completed
• First Posted: February 24, 2010
• Last Update Posted: October 29, 2015
• Sponsor: Medtronic Bakken Research Center
• Information provided by (Responsible Party): Medtronic Cardiovascular ( Medtronic Bakken Research Center )

Tracking Information

• First Submitted Date: January 26, 2010
• First Posted Date: February 24, 2010
• Last Update Posted Date: October 29, 2015
• Study Start Date: June 2009
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: CG Future® Annuloplasty Ring/Band Clinical Trial
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Mitral Valve Insufficiency

Intervention

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

No control arm

There is no control arm as part of the study design.

Intervention: Device: CG Future Annuloplasty Ring/Band

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 27, 2012): 77
• Original Estimated Enrollment (submitted: February 23, 2010): 75
• Actual Study Completion Date: September 2011
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Germany, Greece, Norway, Poland

Administrative Information

• NCT Number: NCT01074671
• Other Study ID Numbers: BRC-CS-2009-06
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Medtronic Cardiovascular ( Medtronic Bakken Research Center )
• Study Sponsor: Medtronic Bakken Research Center
• Collaborators: Not Provided

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

• PRS Account: Medtronic Cardiovascular
• Verification Date: October 2015