Clinical Trial

Beating Heart Mitral Valve Repair With the HARPOON™ System

Study acronym: RESTORE
Active, Not Recruiting
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Summary
The objective of the study is to evaluate the safety and effectiveness of the HARPOON™ System in the treatment of patients with severe degenerative mitral regurgitation (DMR).
Protocol Amendment History 23 amendments
This ClinicalTrials.gov record has been amended 23 times since 2020-05-04; most recent amendment 2025-08-25.
Status change: Recruiting → Active, Not Recruiting 2022-12-01
Status change: Withheld → Recruiting 2020-10-23
Trial Details
NCT Number NCT04375332
Lead Sponsor Edwards Lifesciences
Conditions Mitral Regurgitation
Enrollment 25 participants
Start Date 2020-12-16
Primary Completion 2027-12-20 (estimated)
Study Completion 2027-12-20 (estimated)
Updated on ClinicalTrials.gov 2025-08-26