ChordArt System for Mitral Regurgitation

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-21

Study Completion Date

2023-12-31

Brief Summary

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The ChordArt System is a novel catheter based technology for mitral chordal replacement that enables controlled implantation of artificial mitral chords to treat mitral regurgitation with a minimally invasive approach. The implant is designed to allow transfemoral antegrade implantation.

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Detailed Description

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ChordArt utilizes a minimally invasive catheter based approach by which multiple artificial chordae are precisely positioned into the papillary muscle and then secured to the pathological leaflet.

Conditions

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Mitral Valve Repair Mitral Regurgitation Mitral Valve Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm, multi-center, prospective, non-randomized study. The study is conducted in accordance with the guidelines of the Mitral Valve Academic Research Consortium (MVARC) regarding study design and endpoint definition as well as International Standards Organization 5840-3.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm

The ChordArt System is intended for chordal replacement in patients with mitral valve insufficiency due to leaflet prolapse or flail delivered through a catheter based technology for mitral chordal replacement via a small incision in the thorax.

Group Type EXPERIMENTAL

ChordArt System

Intervention Type DEVICE

The ChordArt System is intended for chordal replacement in mitral valve insufficiency due to leaflet prolapse or flail. One or more ChordArt System may be utilized within the same intervention for optimal mitral valve treatment.

Interventions

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ChordArt System

The ChordArt System is intended for chordal replacement in mitral valve insufficiency due to leaflet prolapse or flail. One or more ChordArt System may be utilized within the same intervention for optimal mitral valve treatment.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Mitral Regurgitation due to degenerative mitral leaflet prolapse or flail
* Left Ventricular Ejection Fraction \>20%
* New York Heart Association functional class II to IV
* Able and willing to give informed consent and follow protocol procedures.

Exclusion Criteria

* Life expectancy \<1 year
* Hemodynamic instability
* Severe untreated ischemic disease
* Pulmonary Hypertension
* Any prior mitral valve surgery or transcatheter mitral valve procedure
* Stroke or transient ischemic event within 30 days before randomization
* Patient is pregnant (urine human chorionic gonadotropin (HCG) test result positive), planning to be pregnant or lactating.
* Renal insufficiency
* Acute anemia
* Chronic obstructive pulmonary disease
* Severe right ventricular dysfunction
* Hepatic insufficiency
* Patient is participating in other investigational studies

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No