CG Future® Annuloplasty Ring/Band Clinical Trial
This study has been completed.
Sponsor:
Medtronic Bakken Research Center
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
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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
- Colvin Galloway Future Annuloplasty Ring
- Colvin Galloway Future Annuloplasty Band
- CG Future Annuloplasty Ring
- CG Future Annuloplasty Band
A CG Future Annuloplasty Ring or Band will be implanted, following standard care
Other Names:
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
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 March 01, 2015