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
The objective of the study is to evaluate the safety and effectiveness of the HARPOON System in the treatment of patients with severe DMR.
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.
Dedicated hemostatic introducer
Low-profile (9 Fr) delivery system
Proprietary, self-forming double-helix ePTFE knot
Find a RESTORE trial site near you
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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