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Device

HARPOON™ System for Mitral Valve Regurgitation (RESTORE Trial)

N/A

Waitlist Available

Led By Vinod H. Thourani, MD

Research Sponsored by Edwards Lifesciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is >/= 21 years old.

Be older than 18 years old

Must not have

Severe pulmonary hypertension (pulmonary artery systolic pressure > 60mmHg).

Stroke within 30 days prior to index procedure.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year following the index procedure.

Awards & highlights

Summary

This trial is testing a new device to treat patients with a severe heart condition. The goal is to see if it is safe and effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed but may include complications related to heart procedures such as bleeding, infection risk at the incision site, reactions to anesthesia or materials used in the device itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe high blood pressure in the lungs.

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

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My liver is significantly damaged (Child-Pugh B or higher, or MELD ≥ 13).

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I refuse to receive blood products.

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My heart's pumping ability is severely reduced.

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I have had heart bypass surgery in the past.

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I am not planning to join another clinical trial within the next year.

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I have a leaky heart valve due to a functional issue.

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I have a history of bleeding disorders or low blood counts.

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I have had endocarditis before.

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I have severe hardening of the heart's mitral valve ring.

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I do not have severe heart issues requiring support devices at enrollment.

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I need heart surgery at the same time.

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My kidney function is low (GFR < 45).

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I cannot undergo heart surgery due to chest conditions or past chest radiation.

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My heart's upper part is weak or thin.

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I had a severe heart attack that needed treatment within the last 30 days.

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I have a severe problem with my aortic valve.

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I cannot have a TEE due to issues with my esophagus.

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I cannot tolerate blood thinners or anti-clotting medications after a procedure.

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I have rheumatic heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year following the index procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year following the index procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year following the index procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite Effectiveness Endpoints

Composite Safety Endpoints

Secondary outcome measures

Blood Product Usage

Composite Effectiveness Endpoint

Discharged to Home vs. Other Facility

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: HARPOON™ Beating Heart Mitral Valve Repair SystemExperimental Treatment1 Intervention

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

0 / 22Eligibility criteria met

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor

180 Previous Clinical Trials

62,396 Total Patients Enrolled

Vinod H. Thourani, MDPrincipal InvestigatorDept of Cardiovascular Surgery, Piedmont Heart Institute

3 Previous Clinical Trials

662 Total Patients Enrolled

Konstantinos Koulogiannis, MDPrincipal InvestigatorDepartment of Cardiovascular Medicine Gagnon Cardiovascular Institute

Media Library

HARPOON™ Beating Heart Mitral Valve Repair System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04375332 — N/A

Mitral Valve Regurgitation Research Study Groups: HARPOON™ Beating Heart Mitral Valve Repair System

Mitral Valve Regurgitation Clinical Trial 2023: HARPOON™ Beating Heart Mitral Valve Repair System Highlights & Side Effects. Trial Name: NCT04375332 — N/A

HARPOON™ Beating Heart Mitral Valve Repair System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04375332 — N/A

~5 spots leftby Sep 2025

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