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Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR
Sponsor: HVR Cardio Oy
Summary
Patients with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) will be evaluated for treatment using the CathHELIX Transcatheter Mitral Annuloplasty System.
Official title: A Study to Evaluate the Feasibility and Safety of Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With Functional Mitral Regurgitation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
5
Start Date
2024-11-16
Completion Date
2026-07
Last Updated
2025-09-23
Healthy Volunteers
No
Interventions
Transcatheter Mitral Valve Repair
Mitral valve repair with the CathHELIX Transcatheter Mitral Annuloplasty System in subjects with functional Mitral Regurgitation
Locations (2)
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia, Georgia
Vilnius University Hospital, Santaros Klinikos, Public Institution
Vilnius, Lithuania, Lithuania