HARPOON

RESTORE is a prospective, multicenter, non-randomized trial designed to evaluate the safety and effectiveness of the HARPOON Beating Heart Mitral Valve Repair System in patients with severe degenerative mitral regurgitation (DMR).

Download our patient brochure

RESTORE study and design

Objective

The objective of the study is to evaluate the safety and effectiveness of the HARPOON System in the treatment of patients with severe DMR.

Estimated enrollment

Up to 360 participants are estimated to be enrolled as part of this single group assignment intervention model where all patients are treated with the HARPOON Beating Heart Mitral Valve Repair System.

Eligibility and enrollment criteria

Key inclusion criteria

  • 21 years of age or older.
  • Presence of severe DMR.
  • Mitral valve prolapse that’s isolated in the mid-segment posterior leaflet.

Key exclusion criteria

  • Left ventricular ejection fraction (LVEF) <30%, or severely impaired right ventricular dysfunction as measured by the core lab.
  • Moderate or greater leaflet calcification.
  • Severe mitral annular calcification (MAC).
  • Evidence of anterior or bileaflet prolapse.
  • Functional mitral regurgitation (FMR).

*Refer to Clinical Study Protocol for full inclusion and exclusion criteria

HARPOON Beating Heart Mitral Valve Repair System

Designed to be a less invasive approach to treat severe DMR by:

Performing off-pump on a beating heart – no cardiopulmonary bypass required

Enabling multiple chords to be deployed

Guiding by echocardiography and allowing for real-time chordal adjustment

HARPOON knot deployment

The HARPOON hemostatic introducer contains a silicone valve to minimize bleeding.

ePTFE chords with proprietary self-forming knots are deployed and anchored using the preloaded HARPOON delivery system.

HARPOOn delivery system
image of Dedicated hemostatic introducer

Dedicated hemostatic introducer

image of Low-profile delivery system

Low-profile (9 Fr) delivery system

image of Proprietary, self-forming double-helix ePTFE knot

Proprietary, self-forming double-helix ePTFE knot

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

Los Angeles

Ronald Reagan UCLA Medical Center

Surgeon
Dr. Richard Shemin
Coordinator
Nancy Satou
Site Number: 310-206-4168
Kimberly Lauang
Site Number: 310-825-0082

Newport Beach

Hoag Memorial Hospital Presbyterian

Surgeon
Dr. Anthony Caffarelli
Coordinator
Gene Graham
Site Number: 949-764-4511

Palo Alto

Stanford University Medical Center

Surgeon
Dr. John MacArthur
Coordinator
Tiffany Koyano
Site Number: 650-724-6921

San Franscisco

UCSF Medical Center

Surgeon
Dr. Tom Nguyen
Dr. Vaikom Mahadevan
Coordinator
Marcela Matheus
Site Number: 628-206-4624

Orlando

AdventHealth Orlando

Surgeon
Dr. Kevin Accola
Coordinators
Sandra Houser
Site Number: 407-303-9418

Sarasota

Sarasota Memorial Hospital

Surgeon
Dr. Jonathan Hoffberger
Coordinators
Colleen Lindner
Site Number: 941-917-1669

Atlanta

Piedmont Heart Institute

Surgeon
Dr. Federico Milla
Coordinator
Akimi Rhodes
Site Number: 404-605-2371

Indianapolis

St. Vincent Hospital of Indiana

Surgeon
Dr. David Heimansohn
Coordinator
Cheree Slusher
Site Number: 317-583-7804

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
Jessica Oakley
Site Number: 734-232-9051

Rochester

Mayo Clinical

Surgeon
Dr. Arman Arghami
Phone Number: 507-293-6218
Coordinator
Julie Mathews (Admin Asst.)
Site Number: 507-255-4377

Morristown

Morristown Medical Center

Surgeon
Dr. John Brown
Coordinator
Jessica Bukhari
Site Number: 973-971-8597

New Brunswick

Rutgers Robert Wood Johnson Medical School

Coordinator
Xiaoru Chen
Site Number: 732-235-9027

New York

Weill Cornell

Surgeon
Dr. Stephanie Mick
Coordinator
Nathan Palanparthi
Site Number: 212-746-5594

Durham

Duke University Medical Center

Surgeon
Dr. Jeffrey Gaca
Coordinator
Sarah Casalinova
Site Number: 919-613-5621

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
Coordinators
Regina Hollister
Site Number: 717-645-8617

Murray

Intermountain Heart Institute

Surgeon
Dr. John Doty
Coordinator
Erika Hummel
Site Number: 801-507-4731
RESTORE trial logo

For more details related to the RESTORE trial or to find a site near you, please visit NCT04375332 at ClinicalTrials.gov

Photo of Support Agent

We’re here for you

We are committed to providing the highest levels of customer service to help our patients improve their quality of life. For any questions, please contact the Edwards Patient Support Center.

Give us a call
(888) 713-1564
Advamed logo

As a member of the Advanced Medical Technology Association (“AdvaMed”), Edwards strictly adheres to the requirements of the AdvaMed Code of Ethics on Interactions with Health Care Professionals.

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.

Please update your browserClose this window

Please update to a current version of your preferred browser, this site will perform effectively on the following:

Unable to update your browser?

If you are on a computer, that is maintained by an admin and you cannot install a new browser, ask your admin about it. If you can't change your browser because of compatibility issues, think about installing a second browser for browsing and keep this old one for compatibility