CG Future® Annuloplasty Ring/Band Clinical Trial

Medtronic

Status and phase: Completed; Phase 4

Conditions: Mitral Valve Insufficiency

Treatments: Device: CG Future Annuloplasty Ring/Band

Study type: Interventional

Funder types: Industry

Identifiers

NCT01074671

BRC-CS-2009-06

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 1 patient group

No control arm

Other group

Description:

There is no control arm as part of the study design.

Treatment:

Device: CG Future Annuloplasty Ring/Band