Status:
RECRUITING
Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR
Lead Sponsor:
HVR Cardio Oy
Conditions:
Mitral Valve Regurgitation (Degenerative or Functional)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Transcath...
Eligibility Criteria
Inclusion
- Moderate to severe (3+) or severe (4+) functional mitral regurgitation
- Left ventricular ejection fraction ≥30%
- Symptomatic New York Heart Association (NYHA) Class II to IV).
Exclusion
- Oxygen dependent for COPD
- Active or suspected endocarditis
- Severe symptomatic carotid stenosis
- Has undergone heart transplantation.
- Severe calcification of the mitral annulus or leaflets
- Coronary sinus anatomy that may preclude proper treatment with the device
Key Trial Info
Start Date :
November 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT07188233
Start Date
November 16 2024
End Date
July 1 2026
Last Update
September 23 2025
Active Locations (2)
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1
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia, Georgia
2
Vilnius University Hospital, Santaros Klinikos, Public Institution
Vilnius, Lithuania, Lithuania