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2019-05 RESTORE - A Prospective, Multi-Center Trial to Evaluate the Safety and Effectiveness of Being Heart Mitral Valve Repair with the Harpoon System

NCT04375332

RESTORE - A Prospective, Multi-Center Trial to Evaluate the Safety and Effectiveness of Being Heart Mitral Valve Repair with the Harpoon System

Associated Conditions

Valvular Disease

Principal Investigator

Sponsor

Edwards Lifesciences

The purpose of this study is to evaluate the safety and effectiveness of the HARPOON Beating Heart Mitral Valve Repair System. The study device is not available for purchase in the U.S. and is therefore called an 'investigational device.' This new repair system is being studied to treat patients like you who have severe mitral regurgitation because of damage to one of the leaflets that makes up the valve.

This study is currently enrolling.