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Safety and Early Feasibility Study of the Harpoon Medical Device (EFS) — EFS  

Mitral Valve Insufficiency Clinical Trial

Official title:
Safety and Performance Study of the Harpoon Medical Transapical Suturing Device (TSD-5) in Subjects With Degenerative Mitral Regurgitation - EFS/CE Mark Study for the Harpoon Medical Device in Poland

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 NCT02771275
Study type Interventional
Source Edwards Lifesciences
Contact
Status Completed
Phase N/A
Start date February 15, 2015
Completion date July 16, 2021
View Details
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