ChordArt System for Mitral Regurgitation

Not Applicable

• Conditions: Mitral Valve Insufficiency; Mitral Valve Repair; Mitral Regurgitation
• Interventions: Device: ChordArt System

• Registration Number: NCT03581656
• Lead Sponsor: CoreMedic GmbH

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-03-21
• Study First Submitted: 2018-06-04
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-07-10
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-09
• Last Update Posted: 2022-07-12
• Primary Completion: 2023-09-10
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm	ChordArt System	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.

Primary Outcome Measures

Name	Time	Method
Major adverse events	At 30 days from implant procedure	The frequency of pre-determined major adverse events
All-cause mortality	At 30 days from implant procedure	The frequency of all-cause mortality

Secondary Outcome Measures

Name	Time	Method
Technical Success	End of Implantation Procedure	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.
Device Performance	At 30 days	The device performance will be measured by the reduction of Mitral Regurgitation by Echocardiography.

Trial Locations

Locations (1)

Vilnius University Hospital Santariskiu Klinikos; 🇱🇹 Vilnius, Lithuania