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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


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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