An interventional study of ChordArt System in Mitral Valve Repair, Mitral Regurgitation and Mitral Valve Insufficiency, sponsored by CoreMedic GmbH. Status unknown at 1 site in Lithuania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-12.
Sponsored by CoreMedic GmbH · Not applicable, Interventional, and Treatment
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.
459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.
This study's enrollment of 5 is below the median of 61 across 274 interventional studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →This is the only study on the registry with CoreMedic GmbH as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
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
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
Plan to share: No
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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