Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07188233

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Mitral Valve Regurgitation (Degenerative or Functional) Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcatheter Mitral Valve Repair

Device

Mitral valve repair with the CathHELIX Transcatheter Mitral Annuloplasty System in subjects with functional Mitral Regurgitation

Primary outcomes

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

    Time frame: Periprocedural

    Technical Device Success: MVARC Technical Success is a definition from the Mitral Valve Academic Research Consortium for evaluating transcatheter mitral valve interventions, defined at the exit from the procedure room and requires all of the following conditions to be met:

    • The patient is alive.
    • There was successful access, delivery, and retrieval of the device delivery system.
    • The first intended device was successfully deployed and correctly positioned.
    • There was freedom from emergency surgery or reintervention related to the device or access procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Fleming

CONTACT

[email protected]

612 940 8037

Sponsors and collaborators

Lead sponsor

HVR Cardio Oy

Industry

Registry information

Official study title

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

Acronym: MARCH

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.