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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07188233

Acronym

MARCH

Enrollment

Registered

2025-09-23

Start date

2024-11-16

Completion date

2026-07-31

Last updated

2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Regurgitation (Degenerative or Functional)

Brief 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.

Interventions

DEVICETranscatheter Mitral Valve Repair

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Technical Device Success (measured at the exit of the catheterization laboratory) is defined per Mitral Valve Academic Research Consortium (MVARC).	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: 1. The patient is alive. 2. There was successful access, delivery, and retrieval of the device delivery system. 3. The first intended device was successfully deployed and correctly positioned. 4. There was freedom from emergency surgery or reintervention related to the device or access procedure.

Countries

Georgia, Lithuania

Contacts

Primary ContactThomas Fleming

tom@hvrcardio.com612 940 8037

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026