ChordArt System for Mitral Regurgitation (CHAGALL)

CoreMedic

Status: Active, not recruiting

Conditions: Mitral Valve Repair; Mitral Valve Insufficiency; Mitral Regurgitation

Treatments: Device: ChordArt System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03581656

PR-000274-001

CHAGALL (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Arm

Experimental group

Description:

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.

Treatment:

Device: ChordArt System