Clinical trial NCT01074671: CG Future® Annuloplasty Ring/Band Clinical Trial
Official title: Colvin-Galloway Future® Annuloplasty Ring/Band Clinical Trial: Interventional Multi-center Prospective Clinical Outcome Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mitral Valve Insufficiency
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2010-02-24
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Identification of the patient population for which a CG Future Annuloplasty Ring or Band is chosen to repair the mitral valve insufficiency
timeFrame: Within 3 months prior to implantation
measure: The percentage of patients that are chronically relieved from mitral valve insufficiency
timeFrame: Within 3 months prior to implantation and at 9 month follow-up
measure: The level of mitral valve regurgitation
timeFrame: Within 3 months prior to implantation and at 9 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Gent
country: Belgium
facility: UZ Gent
city: Hasselt
country: Belgium
facility: Virga Jesse Hospital
city: Dresden
country: Germany
facility: Technische Universitat Dresden
city: Hamburg
country: Germany
facility: Albertinen Krankenhaus Hamburg
city: Athens
country: Greece
facility: Athens Medical Center
city: Bergen
country: Norway
facility: Haukeland Universitetssykehus
city: Rzeszów
country: Poland
facility: Szpital Wojewódzki Nr 2 w Rzeszowie
Study officials:
affiliation: Athens Medical Center, Greece
name: D C Iliopoulos, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Virga Jesse Hospital, Hasselt, Belgium
name: M Hendrikx, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Gent, Belgium
name: K François, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques Universitaires Saint Luc, Brussels, Belgium
name: G El Khoury, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Szpital Wojewódzki Nr 2 w Rzeszowie, Poland
name: K Widenka, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Haukeland Universitetssykehus, Bergen, Norway
name: R. Haaverstad, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Technische Universitat Dresden, Germany
name: K Matschke, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Albertinen Krankenhaus Hamburg, Germany
name: F Riess, Dr.
role: PRINCIPAL_INVESTIGATOR
References: