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 ]

Placement of at least one ePTFE chordae tendineae using the TSD-5 AND a reduction in mitral regurgitation <= 2+ at the time of procedure AND at 30 days


Original Primary Outcome: Same as current

Current Secondary Outcome: Procedural Safety [ Time Frame: 30 days ]

Safety as assessed by Serious Adverse Events


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