NCT03285724

Safety and Performance Study of the Harpoon Mitral Valve Repair System

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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	The Harpoon Medical Transapical device is intended to be used to reduce the degree of degenerative mitral regurgitation by delivering and anchoring one or more ePTFE cords to the affected mitral valve leaflet(s) via a small left thoracotomy on the beating heart in patients with anterior, bi-leaflet or posterior prolapse.

Timeline

• Start date: 2017-05-16
• Primary completion: 2017-06-16
• Completion: 2018-04-20
• First posted: 2017-09-18
• Last updated: 2019-11-19
• Results posted: 2019-10-14

Locations

2 sites across 1 country: Poland

Regulatory

• FDA-regulated device study