CG Future® Annuloplasty Ring/Band Clinical Trial
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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
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Condition or disease | Intervention/treatment | Phase |
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Mitral Valve Insufficiency | Device: CG Future Annuloplasty Ring/Band | Phase 4 |
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 |
Arm | Intervention/treatment |
---|---|
No control arm
There is no control arm as part of the study design.
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Device: CG Future Annuloplasty Ring/Band
A CG Future Annuloplasty Ring or Band will be implanted, following standard care
Other Names:
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- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
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 |
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 |
Mitral Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |