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

RecruitingNAAges 18 Years - anyAllHVR Cardio Oy
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Transcatheter Mitral Valve Repair
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Where

2 sites
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia
Vilnius University Hospital, Santaros Klinikos, Public Institution
Vilnius, Lithuania
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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