HARPOON™ System for Mitral Valve Regurgitation

(RESTORE Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the HARPOON™ System, which aims to assist people with severe degenerative mitral regurgitation. This heart condition occurs when the mitral valve doesn't close properly, causing blood to leak backward. The trial seeks to determine if this system can safely and effectively repair the valve while the heart continues to beat. Individuals diagnosed with severe degenerative mitral regurgitation and experiencing symptoms like shortness of breath or fatigue might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to innovative treatment options.

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 prior data suggests that the HARPOON™ System is safe for treating mitral valve regurgitation?

Research has shown that the HARPOON™ Beating Heart Mitral Valve Repair System is promisingly safe for treating degenerative mitral valve disease. Studies indicate that the procedure was technically successful in 95% of patients, meaning the device worked as expected in almost all cases.

Additionally, early studies have found the system to be both safe and effective. Patients checked up to six months after the procedure showed positive results. Few reports of serious side effects suggest that the treatment is generally well-tolerated.

These findings offer a reassuring view of the HARPOON™ system's safety for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The HARPOON™ Beating Heart Mitral Valve Repair System is unique because it offers a minimally invasive approach to treating mitral valve regurgitation, a condition traditionally managed with open-heart surgery. Unlike conventional treatments that require stopping the heart, the HARPOON™ system allows for repair while the heart is still beating, potentially reducing recovery time and associated risks. Researchers are excited because this innovative technique could lead to faster patient recovery and fewer complications, making it a promising alternative to existing surgical options.

What evidence suggests that the HARPOON™ System is effective for mitral valve regurgitation?

Research has shown that the HARPOON™ Beating Heart Mitral Valve Repair System, which trial participants will receive, holds promise for individuals with severe degenerative mitral regurgitation (DMR). In one study, the procedure succeeded in 95% of patients. Another report found that the main goal was achieved in 90% of patients, with few complications. This system aims to avoid open-heart surgery, potentially leading to quicker recovery and fewer risks. Early results suggest it is safe and effective for treating this heart valve issue. ^{4 5 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04375332

Beating Heart Mitral Valve Repair With the HARPOON ... 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 ...

2. umms.org umms.org/ummc/pros/physician-briefs/heart-vascular/mitral-valve/harpoon-mitral-valve-repair

Pioneering an Alternative to Open-Heart Surgery for ... Results of Earlier HARPOON Trials · Technical success was achieved in 95 percent of patients treated with the HARPOON system. · One year after their procedures, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7559944/

Intensive Care and Anesthesia Management for ... In early studies, the HARPOON Beating Heart MVRS appears to be both safe and effective at treating degenerative mitral valve disease. Outcome data up to 6 ...

4. jacc.org jacc.org/doi/10.1016/j.jacc.2017.10.062

Beating-Heart Mitral Valve Repair Using a Novel ePTFE ... Results: The primary endpoint was met in 27 of 30 patients (90%). Three patients required conversion to open mitral surgery. There were no deaths, ...

5. mayo.edu mayo.edu/research/clinical-trials/cls-20509317

A Study to Evaluate the Safety and Effectiveness of Beating ... The purpose of this study is to evaluate the safety and effectiveness of the HARPOON System in the treatment of patients with severe degenerative mitral ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03285724

Safety and Performance Study of the Harpoon Mitral Valve ... The primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device. ... The device is designed to reduce the degree of ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33038223/

Safety and performance of a novel transventricular beating ... This initial clinical experience with the HARPOON beating heart mitral valve repair system demonstrates encouraging early safety and performance.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04375332

NCT04375332 | Beating Heart Mitral Valve Repair With the ... 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 ...