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
Los Angeles
| Surgeon: | Dr. Mark Cunningham |
| Coordinator: | Stephanie Mullin Site Number: 323-430-3960 |
Palo Alto
Stanford University Medical Center
| Surgeon: | Dr. John MacArthur |
| Coordinator: | Tiffany Koyano Site Number: 650-724-6921 |
Atlanta
| Surgeon: | Dr. Federico Milla |
| Coordinator: | Denise Whyte Site Number: 404-605-3561 |
Baltimore
University of Maryland Medical Center
| Surgeon: | Dr. Murtaza Dawood |
| Coordinator: | N/A Site Number: 410-328-5842 |
Boston
Massachusetts General Hospital
| Surgeon: | Dr. Serguei Melnitchouk |
| Coordinator: | Annika Gallandt Site Number: 617-643-9324 |
Ann Arbor
University of Michigan Health System
| Surgeon: | Dr. Matthew Romano |
| Coordinator: | Nicole Shuler Site Number: 734-232-4297 |
St. Louis
Barnes Jewish / Washington University
| Surgeon: | Dr. Spencer Melby |
| Coordinator: | Marci Damiano Site Number: 314-747-6969 |
Philadelphia
Hospital of the University of Pennsylvania
| Surgeon: | Dr. William Szeto |
| Coordinators: | Eva Laverty Site Number: 215-300-7456 Marissa Konig Site Number: 215-662-8456 |
Wormleysburg
UPMC/Pinnacle Health Hospitals
| Surgeon: | Dr. Mubashir Mumtaz |
| Coordinator: | Regina Hollister 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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