A Study to Evaluate the Feasibility and Safety of Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With Functional Mitral Regurgitation
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
Georgia
Tbilisi Heart and Vascular Clinic
RECRUITING
Tbilisi
Lithuania
Vilnius University Hospital, Santaros Klinikos, Public Institution
RECRUITING
Vilnius
Contact Information
Primary
Thomas Fleming
tom@hvrcardio.com
612 940 8037
Time Frame
Start Date: 2024-11-16
Estimated Completion Date: 2026-07
Participants
Target number of participants: 5
Treatments
Other: Single Arm
Related Therapeutic Areas
Sponsors
Leads: HVR Cardio Oy