Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHVR Cardio Oy
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
Oxygen dependent for COPD
Active or suspected endocarditis
Severe symptomatic carotid stenosis
Has undergone heart transplantation.
Trial design
Treatments tested in this trial
- Transcatheter Mitral Valve Repair
Treatment groups
5 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov