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CE Mark Study for the Harpoon Medical Device — TRACER  

Mitral Valve Insufficiency Clinical Trial

Official title:
Mitral TRans-Apical neoChordal Echo-guided Repair (TRACER) Trial

Clinical Trial Summary

The purpose of this study is to evaluate the safety and performance of the Harpoon Medical device. It is anticipated, that the Harpoon Medical device will provide advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TOE-guided chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

Clinical Trial Description

The device is designed to reduce the degree of mitral regurgitation by delivering and anchoring artificial chordae tendineae to the affected mitral valve leaflet(s) in a beating heart. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02768870
Study type Interventional
Source Edwards Lifesciences
Contact
Status Completed
Phase N/A
Start date April 28, 2016
Completion date September 6, 2022
View Details
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