RecruitingNot Applicable

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

Georgia, Lithuania5 participantsStarted 2024-11-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Technical Device Success (measured at the exit of the catheterization laboratory) is defined per Mitral Valve Academic Research Consortium (MVARC).

Timeframe: Periprocedural

Trial details

NCT IDNCT07188233

SponsorHVR Cardio Oy

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Thomas Fleming

612 940 8037 tom@hvrcardio.com

View on ClinicalTrials.gov More Mitral Valve Regurgitation (Degenerative or Functional) trials