Female Patient

HARPOON Beating Heart Mitral Valve Repair System

A new trial of a minimally invasive treatment for severe degenerative mitral regurgitation

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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?

The HARPOON system is an investigational device designed to repair the damaged mitral valve on a beating heart.

How does it work?

1
Echo screening and clinical assessments to determine eligibility
2
HARPOON procedure performed by a heart surgery team in an operating room
3

Post-procedure doctor's visits and additional testing

Post-procedure timeline

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

Keck Medicine of USC

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

Piedmont Heart Institute

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

Ann Arbor

University of Michigan Health System

Surgeon: Dr. Matthew Romano
Coordinator: Nicole Shuler
Site Number: 734-232-4297

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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