Beating Heart Mitral Valve REPair With the HARPOON™ System: ReaL World Outcomes From a multICenter observATional European Registry

Edwards Lifesciences7 sites in 3 countries26 target enrollmentOctober 2, 2020

ConditionsSevere Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse
Sponsor: Edwards Lifesciences
Enrollment: 26
Locations: 7
Primary Endpoint: Freedom From Re-operation Due to Recurrent Severe Mitral Regurgitation Through 1-year Post-implant
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.

Detailed Description

This is a single arm, prospective, multicenter, post-market, observational registry that will evaluate subjects for up to 5 years post treatment.

Registry

clinicaltrials.gov

Start Date

October 2, 2020

End Date

November 17, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Edwards Lifesciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who are clinically suitable for treatment with the HARPOON™ System, as per the Instructions for Use (IFU), will be evaluated for inclusion in the registry.