HARPOON™ System for Mitral Valve Regurgitation

(RESTORE Trial)

Recruiting at 31 trial locations

Overseen By Jay Donosky

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Disqualifiers: Severe pulmonary hypertension, Severe aortic stenosis, Severe tricuspid regurgitation, Renal insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: During index procedure

25 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of the study is to evaluate the safety and effectiveness of the HARPOON™ System in the treatment of patients with severe degenerative mitral regurgitation (DMR).

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the HARPOON™ Beating Heart Mitral Valve Repair System treatment for mitral valve regurgitation?

The HARPOON™ Beating Heart Mitral Valve Repair System has been shown to safely and effectively treat degenerative mitral valve prolapse by implanting artificial cords on a beating heart, guided by advanced echocardiographic imaging. Initial studies have demonstrated its efficacy and safety for repairing mitral valve disease, with successful outcomes in the first 60 procedures. ^{1 2 3 4 5}

Is the HARPOON System for Mitral Valve Regurgitation safe for humans?

The HARPOON System has been shown to be safe in studies for treating mitral valve regurgitation, with procedures performed on a beating heart using echocardiographic guidance. Initial experiences with the system have demonstrated its safety and effectiveness in humans. ^{1 2 3 4 6}

How is the HARPOON™ System treatment for mitral valve regurgitation different from other treatments?

The HARPOON™ System is unique because it allows for mitral valve repair on a beating heart without the need for stopping the heart or using a heart-lung machine. It uses a minimally invasive approach to implant artificial cords on the mitral valve with the help of echocardiographic guidance, making it less invasive than traditional open-heart surgery. ^{1 2 3 4 6}

Research Team

Vinod H. Thourani, MD

Principal Investigator

Dept of Cardiovascular Surgery, Piedmont Heart Institute

Konstantinos Koulogiannis, MD

Principal Investigator

Department of Cardiovascular Medicine Gagnon Cardiovascular Institute

Eligibility Criteria

This trial is for adults over 21 with severe degenerative mitral regurgitation due to a specific issue in the heart's valve. Participants must be able to give consent, attend follow-ups, and not have conditions like functional mitral regurgitation, certain heart diseases, kidney issues stage 3b or worse, recent or planned major surgeries, life expectancy under a year, or any condition that affects study compliance.

Inclusion Criteria

I can make my own medical decisions and can attend all required study visits.

Your mitral valve can close properly to reduce leaking, as determined by a special heart test.

I am 21 years old or older.

Exclusion Criteria

I have severe high blood pressure in the lungs.

I have not had a stroke in the last 30 days.

I have severe leakage in my heart's tricuspid valve.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the HARPOON™ Beating Heart Mitral Valve Repair System procedure

During index procedure

1 visit (in-person)

Hospitalization

Participants remain in the hospital post-procedure until discharge

Post index procedure until discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

• HARPOON™ Beating Heart Mitral Valve Repair System

Trial Overview The HARPOON™ Beating Heart Mitral Valve Repair System is being tested for its safety and effectiveness in treating patients with severe degenerative mitral regurgitation. The system aims to repair the heart valve while it's still beating without needing traditional open-heart surgery.

Participant Groups

Group I: HARPOON™ Beating Heart Mitral Valve Repair System Experimental Treatment 1 Intervention

Subjects who were treated with the HARPOON™ Beating Heart Mitral Valve Repair System

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

References

1. India pubmed.ncbi.nlm.nih.gov

Intensive care and anesthesia management for HARPOON beating heart mitral valve repair. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Transoesophageal echo-guided mitral valve repair using the Harpoon system. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Echocardiographic guidance for HARPOON beating-heart mitral valve repair. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

Transcatheter edge to edge repair using the ease-of-use valve clamp system for functional mitral regurgitation: a primary report. [2023]

5. France pubmed.ncbi.nlm.nih.gov

Leaflet edge-to-edge treatment versus direct annuloplasty in patients with functional mitral regurgitation. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Actual perspective on off-pump transapical artificial chord implantation. [2022]