Status:
ACTIVE_NOT_RECRUITING
Paired-Ring Mitral Annuloplasty Ring Sizing Device
Lead Sponsor:
Endeavor Health
Conditions:
Heart Valve Diseases
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate a novel paired-ring mitral annuloplasty sizing system in humans.
Detailed Description
This is a pilot feasibility study of an investigational device. The proposed device is designed to be used as a temporary, disposable tool that will guide final ring size selection during mitral valve...
Eligibility Criteria
Inclusion
- All patients scheduled for mitral repair surgery
- Age 18 years or older
Exclusion
- Adults unable to consent,
- Pregnant women and prisoners.
- Emergency operations and those patients in whom mitral repair is not performed in a meaningful way, requiring mitral replacement instead, will be excluded.
- Presence of acute endocarditis infection during the initial screening process
Key Trial Info
Start Date :
July 3 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06965725
Start Date
July 3 2025
End Date
November 1 2026
Last Update
July 15 2025
Active Locations (1)
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1
Endeavor Health
Glenview, Illinois, United States, 60026