Actively Recruiting
Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR
Led by HVR Cardio Oy · Updated on 2025-09-23
5
Participants Needed
2
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia, Georgia
Actively Recruiting
2
Vilnius University Hospital, Santaros Klinikos, Public Institution
Vilnius, Lithuania, Lithuania
Actively Recruiting
Research Team
T
Thomas Fleming
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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