CE Mark Study for the Harpoon Medical Device in Poland

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant 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 TEE-guided chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

Clinical Trial Description

The TSD-5 is intended to secure ePTFE sutures on the mitral valve for the treatment of mitral valve disease. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02432196
Study type	Interventional
Source	Edwards Lifesciences
Contact
Status	Completed
Phase	N/A
Start date	December 11, 2015
Completion date	November 16, 2022

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See also
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