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NCT03581656 Clinical Trial

ChordArt System for Mitral Regurgitation

Mitral Regurgitation Clinical Trial

— CHAGALL  

Official title:
ChordArt System Study for the Treatment of Mitral Regurgitation Due to Leaflet Prolapse or Flail

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03581656
Other study ID # PR-000274-001
Secondary ID CHAGALL
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 21, 2018
Est. completion date December 2023

Study information
Verified date July 2022
Source CoreMedic GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 5
Est. completion date December 2023
Est. primary completion date September 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• 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.

Locations
Country Name City State
Lithuania Vilnius University Hospital Santariskiu Klinikos Vilnius

Sponsors (2)
Lead Sponsor Collaborator
CoreMedic GmbH Meditrial Europe Ltd.

Country where clinical trial is conducted

Lithuania, 

References & Publications (2)

Mohty D, Orszulak TA, Schaff HV, Avierinos JF, Tajik JA, Enriquez-Sarano M. Very long-term survival and durability of mitral valve repair for mitral valve prolapse. Circulation. 2001 Sep 18;104(12 Suppl 1):I1-I7. — View Citation

Urbanski PP. Modified technique of chordal replacement for mitral valve repair. Thorac Cardiovasc Surg. 2005 Oct;53(5):315-7. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary All-cause mortality The frequency of all-cause mortality At 30 days from implant procedure
Primary Major adverse events The frequency of pre-determined major adverse events At 30 days from implant procedure
Secondary 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. End of Implantation Procedure
Secondary Device Performance The device performance will be measured by the reduction of Mitral Regurgitation by Echocardiography. At 30 days
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