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ACTIVE NOT RECRUITING
NCT04375332
NA

Beating Heart Mitral Valve Repair With the HARPOON™ System

Sponsor: Edwards Lifesciences

View on ClinicalTrials.gov

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).

Official title: A Prospective, Multi-center Trial to Evaluate the Safety and Effectiveness of Beating Heart Mitral Valve Repair With the HARPOON™ System (RESTORE)

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2020-12-16

Completion Date

2027-12-20

Last Updated

2025-08-26

Healthy Volunteers

No

Interventions

DEVICE

HARPOON™ Beating Heart Mitral Valve Repair System

Repair of the chordae tendinae in the mitral valve.

Locations (9)

UCSF

San Francisco, California, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Johns Hopkins

Baltimore, Maryland, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

OHSU Knight Cardiovascular Institute

Portland, Oregon, United States

Centennial Medical Center

Nashville, Tennessee, United States

Intermountain Heart Institute

Murray, Utah, United States