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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-16

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Mitral Valve Regurgitation (Degenerative or Functional)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type OTHER

Transcatheter Mitral Valve Repair

Intervention Type DEVICE

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

Interventions

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Transcatheter Mitral Valve Repair

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No