Active, not recruitingNCT04375332

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Beating Heart Mitral Valve Repair With the HARPOON™ System

Edwards LifesciencesMultiple US sitesView on ClinicalTrials.gov

AI Description

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).

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Who can join
adult, older adult
Participants
25
Expected completion
2027-12-20
Funded by
industry

Conditions studied

Mitral Regurgitation

What is being tested

  • DEVICE: HARPOON™ Beating Heart Mitral Valve Repair System

What it measures

  • Change in NYHA classification from Baseline to 5 years, The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest., Baseline compared to 1 and 5 years

Centers Participating

These centers are participating in this study. Reach out to them directly to learn more.

Data Sources and Methodology

Registry entry updated 2026-08-19

Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.

If you would rather we did it with you, call us on (656) 206-4686.