NCT07188233

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: HVR Cardio Oy · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitral Valve Regurgitation (Degenerative or Functional)

Interventions

Type	Name	Description
DEVICE	Transcatheter Mitral Valve Repair	Mitral valve repair with the CathHELIX Transcatheter Mitral Annuloplasty System in subjects with functional Mitral Regurgitation

Timeline

• Start date: 2024-11-16
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-09-23
• Last updated: 2025-09-23

Locations

2 sites across 2 countries: Georgia, Lithuania