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

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

Recruiting
18 years and older
All
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

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 Criteria:

  • 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 Criteria:

  • 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

Study details
    Mitral Valve Regurgitation (Degenerative or Functional)

NCT07188233

HVR Cardio Oy

15 October 2025

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