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).

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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.
  • Presence of severe degenerative mitral regurgitation with mid-segment posterior leafleft prolapse (without commissural involvement) by echocardiographic study.

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 procedure

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

Birmingham

The University of Alabama at Birmingham

Surgeon
James Davies, MD
Coordinator
Destiny Taylor
Site Number: 205-224-2567

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
Jordyn Pinochi
Site Number: 717-782-5937

Hartford

Hartford Hospital

Surgeon
Dr. Sabet Hashim
Coordinators
Jill Cloutier
Site Number: 860-972-2579

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
Hannah Willard
Site Number: 317-583-7804

Baltimore

Johns Hopkins

Surgeon
Dr. Ahmet Kilic
Coordinator
Lisa Fornaresio
Site Number: 410.955.3597

Baltimore

University of Maryland Medical Center

Surgeon
Dr. Bradley Taylor
Coordinator
N/A
Site Number: 410-328-5842

Boston

Massachusetts General Hospital

Surgeon
Dr. Serguei Melnitchouk
Coordinator
Tracy Winship
Site Number: 617-724-7629

Ann Arbor

University of Michigan Health System

Surgeon
Dr. Matthew Romano
Coordinator
Nicole White
Site Number: 734-232-4298

Rochester

Mayo Clinical

Surgeon
Arman Arghami
Phone Number: 507-422-0339
Coordinator
Julie Mathews (Admin Asst.)
Site Number: 507-255-4377

St. Louis

Barnes Jewish Hospital

Surgeon
Dr. Spencer Melby
Coordinator
JKyle Stumbaugh
Site Number: 314-747-0707

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
Meghan Smith
Site Number: 732-235-7800

New York

Weill Cornell

Surgeon
Dr. Stephanie Mick
Coordinator
Marshagay Rodriques
Site Number: 212-746-5594

Durham

Duke University Medical Center

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

Cleveland

Cleveland Clinic

Surgeon
Kevin Hodges, MD

Portland

OHSU Knight Cardiovascular Institute

Surgeon
Ellie Rogge
Site Number: 503-494-6072

Philadelphia

Hospital of the University of Pennsylvania

Surgeon
Dr. William Szeto
Coordinators
Marissa Konig
Site Number: 215-662-8456

Wormleysburg

UPMC/Pinnacle Health Hospitals

Surgeon
Dr. Mubashir Mumtaz
Coordinators
Matthew Rutt
Site Number: 717-782-5937

Pittsburgh

Allegheny General Hospital

Surgeon
Dr. Walter McGregor
Coordinators
Veronica Galuska
Site Number: 412-359-3802

Nashville

Centennial Medical Center

Surgeon
Dr. Sreekumar Subramanian
Site Number: 615-329-6856

Murray

Intermountain Heart Institute

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

Falls Church

Inova Fairfax Hospital

Surgeon
Dr. Eric sarin
Coordinator
Ian Leung
Site Number: 703-776-4096

Seattle

Swedish Medical Center

Surgeon
Dr. Eric Lehr
Coordinator
Janet Zaltsman
Site Number: 206-215-2455
RESTORE trial logo

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

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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
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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.

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