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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year following the index procedure.
Awards & highlights
RESTORE Trial 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.Check my eligibility
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.See study design
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.
RESTORE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older.
RESTORE Trial 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
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 moreRESTORE 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
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Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
61,549 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe high blood pressure in the lungs.I have not had a stroke in the last 30 days.I can make my own medical decisions and can attend all required study visits.I have severe leakage in my heart's tricuspid valve.My liver is significantly damaged (Child-Pugh B or higher, or MELD ≥ 13).I refuse to receive blood products.My heart's pumping ability is severely reduced.I am not pregnant, breastfeeding, or planning to become pregnant in the next year.I have had heart bypass surgery in the past.An ultrasound test shows a mass inside the heart.Your mitral valve can close properly to reduce leaking, as determined by a special heart test.I am not planning to join another clinical trial within the next year.You have a blockage in your carotid artery that is 80% or more.I am 21 years old or older.I currently have or had COVID-19 with lasting effects.I have a leaky heart valve due to a functional issue.I have a history of bleeding disorders or low blood counts.I have not had any heart or blood vessel procedures in the last 30 days.I have had endocarditis before.I have severe hardening of the heart's mitral valve ring.You have a serious problem with the mitral valve in your heart that has been confirmed by an echocardiogram.I do not have severe heart issues requiring support devices at enrollment.I have a heart or blood vessel procedure planned within 30 days after the trial.I need heart surgery at the same time.My kidney function is low (GFR < 45).I cannot undergo heart surgery due to chest conditions or past chest radiation.You have significant calcification on your heart valve.My heart's upper part is weak or thin.I had a severe heart attack that needed treatment within the last 30 days.I have a severe problem with my aortic valve.I have had heart surgery, but stent placements are okay.I cannot have a TEE due to issues with my esophagus.I cannot tolerate blood thinners or anti-clotting medications after a procedure.My condition does not meet any exclusion criteria during surgery.There is evidence of a certain type of heart valve problem.I have rheumatic heart disease.
Research Study Groups:
This trial has the following groups:- Group 1: HARPOON™ Beating Heart Mitral Valve Repair System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have enrolled in the research endeavor?
"Affirmative. According to the clinicaltrials.gov database, this clinical trial is currently recruiting patients starting from December 16th 2020; the most recent update was on September 29th 2022. 360 individuals are being sought out between 32 different sites for enrollment purposes."
Answered by AI
In how many disparate locations is this study being managed?
"In this clinical trial, 32 facilities are actively recruiting patients. These sites include Barnes-Jewish/Washington University in Saint Louis, Rutgers Robert Wood Johnson Medical School in New Brunswick, and Centennial Medical Center in Nashville among other participating centres."
Answered by AI
Is this research venture currently accepting volunteers?
"This clinical study is currently accruing participants, as per the information available on clinicialtrials.gov. The trial was first posted in December 2020 and most recently updated in September 2022."
Answered by AI
What positive changes are anticipated from this trial's results?
"This trial's chief goal, which will be measured for roughly one year post-procedure, is to determine the Composite Safety Endpoints. Auxiliary objectives encompass assessing freedom from all-cause mortality; reintervention on the mitral valve and recurrence of moderate/severe mitral regurgitation in a single year after treatment; percentage of subjects who receive MVR during procedure among HARPOON System recipients versus those go through open surgery; and number discharged at home as opposed to other facility between two groups."
Answered by AI
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