Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
77 participants
INTERVENTIONAL
2009-06-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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No control arm
There is no control arm as part of the study design.
CG Future Annuloplasty Ring/Band
A CG Future Annuloplasty Ring or Band will be implanted, following standard care
Interventions
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CG Future Annuloplasty Ring/Band
A CG Future Annuloplasty Ring or Band will be implanted, following standard care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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D C Iliopoulos, Prof
Role: PRINCIPAL_INVESTIGATOR
Athens Medical Center, Greece
M Hendrikx, Dr
Role: PRINCIPAL_INVESTIGATOR
Virga Jesse Hospital, Hasselt, Belgium
K François, Dr
Role: PRINCIPAL_INVESTIGATOR
UZ Gent, Belgium
G El Khoury, Dr
Role: PRINCIPAL_INVESTIGATOR
Cliniques Universitaires Saint Luc, Brussels, Belgium
K Widenka, Dr
Role: PRINCIPAL_INVESTIGATOR
Szpital Wojewódzki Nr 2 w Rzeszowie, Poland
R. Haaverstad, Prof.
Role: PRINCIPAL_INVESTIGATOR
Haukeland Universitetssykehus, Bergen, Norway
K Matschke, Dr.
Role: PRINCIPAL_INVESTIGATOR
Technische Universitat Dresden, Germany
F Riess, Dr.
Role: PRINCIPAL_INVESTIGATOR
Albertinen Krankenhaus Hamburg, Germany
Locations
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Cliniques Universitaires Saint Luc
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
Virga Jesse Hospital
Hasselt, , Belgium
Technische Universitat Dresden
Dresden, , Germany
Albertinen Krankenhaus Hamburg
Hamburg, , Germany
Athens Medical Center
Athens, , Greece
Haukeland Universitetssykehus
Bergen, , Norway
Szpital Wojewódzki Nr 2 w Rzeszowie
Rzeszów, , Poland
Countries
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Related Links
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Related Info
Other Identifiers
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BRC-CS-2009-06
Identifier Type: -
Identifier Source: org_study_id
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