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Safety and Performance Study of the Harpoon Mitral Valve Repair System

Mitral Valve Insufficiency Clinical Trial

Official title:
Safety and Performance Study of the Harpoon Medical Device in Patients With Degenerative Mitral Regurgitation

Clinical Trial Summary

The primary objective 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 TEE-guided ePTFE cordal 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 NCT03285724
Study type Interventional
Source Edwards Lifesciences
Contact
Status Terminated
Phase N/A
Start date May 16, 2017
Completion date April 20, 2018
View Details
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