NCT02768870

CE Mark Study for the Harpoon Medical Device

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Mitral Valve Regurgitation
• Mitral Valve Prolapse
• Mitral Valve Insufficiency

Interventions

Type	Name	Description
DEVICE	Harpoon Artificial ePTFE Chords	It is anticipated that use of the Harpoon device could achieve similar outcomes to open cardiac surgery while decreasing the invasiveness of mitral valve repair.

Timeline

• Start date: 2016-04-28
• Primary completion: 2017-11-06
• Completion: 2022-09-06
• First posted: 2016-05-11
• Last updated: 2024-01-11
• Results posted: 2019-11-25

Locations

4 sites across 2 countries: Italy, United Kingdom

Regulatory

• FDA-regulated device study