CG Future® Annuloplasty Ring/Band Clinical Trial

Mitral Valve Insufficiency Clinical Trial

Official title:

Colvin-Galloway Future® Annuloplasty Ring/Band Clinical Trial: Interventional Multi-center Prospective Clinical Outcome Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074671
• Other study ID #: BRC-CS-2009-06
• Status: Completed
• Phase: Phase 4
• First received: January 26, 2010
• Last updated: October 28, 2015
• Start date: June 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2015
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics CommitteeBelgium: Institutional Review BoardPoland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mitral Valve Insufficiency

Intervention

Device:
• CG Future Annuloplasty Ring/Band
A CG Future Annuloplasty Ring or Band will be implanted, following standard care

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Brussels
Belgium	UZ Gent	Gent
Belgium	Virga Jesse Hospital	Hasselt
Germany	Technische Universitat Dresden	Dresden
Germany	Albertinen Krankenhaus Hamburg	Hamburg
Greece	Athens Medical Center	Athens
Norway	Haukeland Universitetssykehus	Bergen
Poland	Szpital Wojewódzki Nr 2 w Rzeszowie	Rzeszów

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Countries where clinical trial is conducted

Belgium,  Germany,  Greece,  Norway,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of the patient population for which a CG Future Annuloplasty Ring or Band is chosen to repair the mitral valve insufficiency		Within 3 months prior to implantation	No
Primary	The percentage of patients that are chronically relieved from mitral valve insufficiency		Within 3 months prior to implantation and at 9 month follow-up	No
Primary	The level of mitral valve regurgitation		Within 3 months prior to implantation and at 9 month follow-up	No

External Links

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