NCT02771275

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (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 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.

Detailed description

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

Conditions

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

Interventions

Type	Name	Description
DEVICE	Harpoon Medical Device	It is expected that the Harpoon Medical transapical suturing device will be a valuable treatment alternative for patients suffering from mitral valve regurgitation because it can access the left ventricle with a small shaft or via a small valved introducer with a secure anchoring mechanism that can be deployed anywhere on the mitral valve leaflet.

Timeline

• Start date: 2015-02-15
• Primary completion: 2016-03-21
• Completion: 2021-07-16
• First posted: 2016-05-13
• Last updated: 2024-01-22
• Results posted: 2019-11-25

Locations

2 sites across 1 country: Poland

Regulatory

• FDA-regulated device study