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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 one year following the index procedure
Awards & highlights
No Placebo-Only Group

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 weeks
Treatment ~ Varies
Follow Up ~baseline compared to 1 and 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline compared to 1 and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in NYHA classification from Baseline to 5 years
Secondary study objectives
Blood Product Usage
Composite Effectiveness Endpoint
Discharged to Home vs. Other Facility
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
182 Previous Clinical Trials
63,083 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
~10 spots leftby Dec 2027
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