Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR
A Study to Evaluate the Feasibility and Safety of Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With Functional Mitral Regurgitation
HVR Cardio Oy
5 participants
Nov 16, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria6
- 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
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Interventions
Mitral valve repair with the CathHELIX Transcatheter Mitral Annuloplasty System in subjects with functional Mitral Regurgitation
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07188233