ChordArt System for Mitral Regurgitation

CoreMedic GmbH5 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mitral Valve Repair Mitral Regurgitation Mitral Valve Insufficiency

Interventions

ChordArt SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Vilnius University Hospital Santariskiu Klinikos

Vilnius, Lithuania

Outcomes

Primary Outcomes

All-cause mortality

The frequency of all-cause mortality

Time frame: At 30 days from implant procedure

Major adverse events

The frequency of pre-determined major adverse events

Time frame: At 30 days from implant procedure

Secondary Outcomes

Technical Success

The technical success will be measured by the absence of procedural mortality, successful access, delivery of the ChordArt implant \& retrieval of the ChordArt delivery system as well as successful ChordArt deployment, positioning and freedom from emergency surgery or re-intervention related to the device or access procedure.

Time frame: End of Implantation Procedure

Device Performance

The device performance will be measured by the reduction of Mitral Regurgitation by Echocardiography.

Time frame: At 30 days

Data from ClinicalTrials.gov

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