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Transcatheter Valve
Transcatheter Mitral Valve Replacement for Mitral Valve Disease
N/A
Waitlist Available
Led By Mayra Guerrero, MD
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Surgical bioprosthetic valve with a true internal diameter (True ID) of 16.5 mm to 28.5 mm.
Failing surgically implanted bioprosthetic valve in the mitral position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new heart valve to see if it is safe and effective in patients who have a failing mitral valve.
Who is the study for?
The PARTNER 3 Trial is for patients with a failing mitral valve from a previous surgery, who are at intermediate risk for heart surgery. They must have moderate to severe issues with their valve and symptoms of heart failure (NYHA Class ≥ II). Patients should not have serious kidney disease, recent strokes or heart attacks, life expectancy under 2 years, or be pregnant.Check my eligibility
What is being tested?
This trial tests the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve in patients whose previously implanted surgical bioprosthetic mitral valves are no longer working properly.See study design
What are the potential side effects?
Potential side effects may include risks associated with heart procedures such as bleeding, blood vessel complications, irregular heartbeat requiring a pacemaker, stroke, infection around the valve (endocarditis), or even death.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a surgical heart valve that is between 16.5 mm and 28.5 mm in size.
Select...
My heart valve replacement is not working properly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Effectiveness - Composite of All-cause Mortality and Stroke
Secondary outcome measures
Kansas City Cardiomyopathy Questionnaire (KCCQ) - Change From Baseline
Mitral Regurgitation - Change From Baseline
New York Heart Association (NYHA) Functional Class - Change From Baseline
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Failing mitral transcatheter valveExperimental Treatment1 Intervention
Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.
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Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
61,521 Total Patients Enrolled
Mayra Guerrero, MDPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
1,245 Total Patients Enrolled
Chris S. Malaisrie, MDPrincipal InvestigatorNorthwestern University Feinberg School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My right heart chamber is not working properly.I have a valve in my heart that might affect a new mitral implant.After the original valve surgery, there was still a high level of pressure in the heart.I have severe leaking or narrowing in one of my heart valves.You had a heart attack within the last month.I have symptoms from narrowed neck arteries or had treatment for it within the last month.Doctors think you may live for less than 2 years.I have a serious heart artery problem that hasn't been treated yet.I have not had any emergency surgeries in the last 30 days.I am scheduled for a surgery or heart-related procedure within the next 30 days.I have a thickened heart muscle that obstructs blood flow.Your heart's pumping ability is very low.I refuse to receive blood products.If you are a woman who can have children, you have a positive pregnancy test.I have a surgical heart valve that is between 16.5 mm and 28.5 mm in size.I haven't needed heart or lung support machines in the last 30 days.I have severe lung disease or need home oxygen.I have severe high blood pressure in my lungs.I have not had any heart-related surgery with a permanent implant, except for a pacemaker or defibrillator, in the last 30 days.I am scheduled for a procedure to correct atrial fibrillation.I have low white blood cells, anemia, low platelets, bleeding disorders, or clotting issues.I cannot take blood thinners during or after my valve implant surgery.My kidney function is very low or I am on dialysis.I have not had active bacterial endocarditis in the last 6 months.My heart valve replacement is not working properly.I have not had a stroke or TIA in the last 90 days.A team of heart doctors thinks that getting a valve implant will help the patient.A group of heart doctors decides that the patient has a moderate risk for a heart-related procedure.Your heart imaging shows abnormal growths, blood clots, or infections.You have heart problems that affect your ability to do physical activities.The surgical valve in your heart has a leak that is not securely fitted or is damaged, as shown by a specific type of heart test called transesophageal echocardiography (TEE).My body's structure allows safe access for medical procedures.My heart's structure increases my risk of a blockage in the outflow tract.
Research Study Groups:
This trial has the following groups:- Group 1: Failing mitral transcatheter valve
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.
Is this research trial still open for recruitment?
"Data hosted on clinicaltrials.gov suggests that this specific trial is no longer recruiting participants. It was first posted in February of 2018 and was last updated October 14th 2022, yet there are currently 794 other studies searching for candidates."
Answered by AI
How extensively is this experiment being administered in health facilities?
"This clinical trial is available in 15 different locations, including Henry Ford Hospital in Detroit, Northwestern University in Chicago, and Brigham and Women's Hospital of Boston. Plus an additional 12 sites."
Answered by AI
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