NCT04820764Active, not recruitingNot Applicable
Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- CardioMech AS
- Enrollment
- 35
- Locations
- 36
- Primary Endpoint
- Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure
Study Overview
Brief Summary
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Detailed Description
The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe (≥3+) or severe (≥4+), symptomatic, degenerative mitral regurgitation and who are determined to be at intermediate or high surgical risk for mitral valve repair, as assessed by the site's multidisciplinary heart team.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eighteen (18) years of age or greater
- •Moderate to severe (≥3+) or severe (≥4+) mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail
- •Intermediate or high surgical risk for mitral valve repair
Exclusion Criteria
- •History of rheumatic heart disease
- •History of prior endocarditis
- •History of prior repair or replacement of the mitral valve, or annuloplasty
- •Severely calcified mitral leaflet or has evidence of calcification in the grasping area of the leaflets that would prevent leaflet anchor positioning and deployment
- •Complex mechanism of MR (leaflet perforation, severe leaflet calcifications, commissural extension, commissural prolapse, multiple flail or prolapsing segments, cleft) present on required imaging
Arms & Interventions
CardioMech Mitral Valve Repair System (MVRS)
Experimental
Intervention: CardioMech MVRS (Device)
Outcomes
Primary Outcomes
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure
Time Frame: 30 days
Change in MR grade
Time Frame: 30 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (36)
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