Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR

Recruiting now · Not applicable

Conditions studied: Mitral Valve Regurgitation (Degenerative or Functional)

In brief

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.

Key facts

Study ID

NCT07188233

Run by

HVR Cardio Oy

People needed

5

Starts

2024-11-16

Expected to finish

2026-07-01

Last updated by the study team

2025-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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

Where it is running

• Tbilisi Heart and Vascular Clinic — Tbilisi, Georgia, Georgia (enrolling)
• Vilnius University Hospital, Santaros Klinikos, Public Institution — Vilnius, Lithuania, Lithuania (enrolling)

Full record on ClinicalTrials.gov

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