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

RECRUITINGN/ASponsored by HVR Cardio Oy
Actively Recruiting
PhaseN/A
SponsorHVR Cardio Oy
Started2024-11-16
Est. completion2026-07
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07188233

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Heart DiseaseMitral Valve Regurgitation (Degenerative or Functional)

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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