Colvin-Galloway Future® Annuloplasty Ring/Band Clinical Trial: Interventional Multi-center Prospective Clinical Outcome Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 77
- Locations
- 16
- Primary Endpoint
- The level of mitral valve regurgitation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
No control arm
There is no control arm as part of the study design.
Intervention: CG Future Annuloplasty Ring/Band (Device)
Outcomes
Primary Outcomes
The level of mitral valve regurgitation
Time Frame: Within 3 months prior to implantation and at 9 month follow-up
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
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
Secondary Outcomes
No secondary outcomes reported