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Recruiting NCT07188233

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

No phase Interventional Mitral Valve Regurgitation (Degenerative or Functional)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcatheter Mitral Valve Repair.
Who it may be relevant to
Registry conditions: Mitral Valve Regurgitation (Degenerative or Functional). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Georgia, Lithuania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Study to Evaluate the Feasibility and Safety of Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With Functional Mitral Regurgitation

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.

Interventions

  • Device Transcatheter Mitral Valve Repair
    Mitral valve repair with the CathHELIX Transcatheter Mitral Annuloplasty System in subjects with functional Mitral Regurgitation

Primary outcome measures

  • Technical Device Success (measured at the exit of the catheterization laboratory) is defined per Mitral Valve Academic Research Consortium (MVARC). [Time frame: Periprocedural]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

Georgia · 1 center
  • Tbilisi Heart and Vascular Clinic — Tbilisi
Lithuania · 1 center
  • Vilnius University Hospital, Santaros Klinikos, Public Institution — Vilnius

Identifiers

NCT: NCT07188233 · CIP-2023-008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗