TerminatedNot Applicable

Observational Registry on the HARPOON Device

Stopped: Low enrollment

Germany26 participantsStarted 2020-10-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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. Exclusion Criteria: * N/A

What they're measuring

Freedom From Re-operation Due to Recurrent Severe Mitral Regurgitation Through 1-year Post-implant

Timeframe: 1 year post-implant

Trial details

NCT IDNCT04393779

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-17

Results submitted2023-12-07

View on ClinicalTrials.gov More Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse trials