Clinical Trial: Safety and Early Feasibility Study of the Harpoon Medical Device
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: First In Man - Clinical Validation of the TSD-5
Brief Summary: This is a Prospective, Single Arm, Single Group Assignment, EU study to demonstrate the feasibility and safety of the Harpoon Medical TSD-5 in subjects with degenerative MR
Detailed Summary: Pairs of ePTFE suture will be placed in the posterior leaflet of the mitral valve using the Harpoon Medical TSD-5 in order to establish effective coaptation of the mitral leaflets
Sponsor: Harpoon Medical
Current Primary Outcome: Procedural Success [ Time Frame: 30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Procedural Safety [ Time Frame: 30 days ]
Original Secondary Outcome: Same as current
Information By: Harpoon Medical
Dates:
Date Received: April 27, 2015
Date Started: February 2015
Date Completion: February 2020
Last Updated: August 15, 2016
Last Verified: August 2016