HARPOON Beating Heart Mitral Valve Repair System
A new trial of a minimally invasive treatment for severe degenerative mitral regurgitation
What is degenerative mitral regurgitation?
Degenerative mitral regurgitation is a condition in which the valve’s two flap-like leaflets and supporting string-like structures (chords) are too stretchy and may even break.
When the heart contracts, the valve’s leaflets may not close correctly. This causes regurgitation, which occurs when blood leaks backward into the left atrium with each heartbeat.
Symptoms
- Chest pain
- Lightheadedness
- Shortness of breath
- Fatigue
- Fainting
- Difficulty when exercising
However, some patients may not experience any symptoms at all.
What is the HARPOON system?
How does it work?
Post-procedure doctor's visits and additional testing
You may qualify if you:
- Are 21 years of age or older.
- Have mitral valve prolapse that is isolated in the mid-segment of the posterior leaflet.
- Have severe degenerative mitral regurgitation.
Talk to your doctor or the clinical trial coordinator about the full list of eligibility criteria.
You may not qualify if you:
- Have secondary or functional mitral regurgitation caused by other forms of heart disease.
- Have mitral valve prolapse in the anterior leaflet or both leaflets.
- Had any prior heart valve repair or replacement surgery
- Are scheduled to have other cardiac procedures at the same time.
- Are scheduled to have other cardiac or peripheral vascular procedures 30 days before or after the trial procedure.
Where can I participate?
Continue the conversation with your cardiologist to determine if the RESTORE trial is right for you or find a heart surgeon participating in the trial below.
Find a RESTORE trial site near you
Palo Alto
Stanford University Medical Center
Surgeon
Coordinator
Site Number: 650-724-6921
Atlanta
Piedmont Heart InstituteSurgeon
Coordinator
Site Number: 404-605-2371
Indianapolis
St. Vincent Hospital of Indiana
Surgeon
Coordinator
Site Number: 317-583-7804
Baltimore
University of Maryland Medical CenterSurgeon
Coordinator
Site Number: 410-328-5842
Boston
Massachusetts General HospitalSurgeon
Coordinator
Site Number: 617-643-9324
Ann Arbor
University of Michigan Health System
Surgeon
Coordinator
Site Number: 734-232-9051
Rochester
Mayo ClinicalSurgeon
Phone Number: 507-293-6218
Coordinator
Site Number: 507-255-4377
St. Louis
Barnes Jewish / Washington UniversitySurgeon
Coordinator
Site Number: 314-362-3043
Durham
Duke University Medical Center
Surgeon
Coordinator
Site Number: 919-613-5621
Wormleysburg
UPMC/Pinnacle Health HospitalsSurgeon
Coordinators
Site Number: 717-645-8617
Caution: Investigational device. Limited by Federal (United States) law to investigational use. The device is not available for marketing or commercial sale in the United States. Edwards Lifesciences is the sponsor of the RESTORE trial.
Edwards, Edwards Lifesciences, the stylized E logo and HARPOON are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are property of their respective owners.
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