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Transcatheter Heart Valve
Aortic Valve-in-Valve for Aortic Stenosis (P3-AVIV Trial)
N/A
Recruiting
Led By Chris S Malaisrie, MD
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm
Must not have
Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic)
Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial will study whether a new heart valve is safe and effective in people with an existing failing heart valve.
Who is the study for?
This trial is for patients with a failing aortic bioprosthetic valve showing significant stenosis or insufficiency. Candidates should have an internal diameter of their current valve between 18.5 and 28.5 mm, be in NYHA Functional Class II or higher, and considered low to intermediate surgical risk by the Heart Team.
What is being tested?
The PARTNER 3 Trial tests the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) as a replacement for failing bioprosthetic valves in the aortic position.
What are the potential side effects?
Potential side effects may include risks associated with heart valve replacement such as blood clots, bleeding, infection, stroke, irregular heart rhythms, or issues related to improper placement or function of the new valve.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart valve replacement is not working well, showing significant narrowing or leakage.
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My heart valve replacement is between 18.5 mm and 28.5 mm in size.
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My heart valve replacement is not working properly.
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I have some limitations on physical activity due to heart problems.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My body's structure allows safe access to my heart's main artery.
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I haven't needed heart or lung support machines in the last 30 days.
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I have a thickened heart muscle that obstructs blood flow.
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I am scheduled for a procedure to treat Atrial Fibrillation.
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I have a heart condition that hasn't been treated with surgery.
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I have a history of blood disorders or abnormal bleeding.
Select...
My heart's pumping ability is severely reduced.
Select...
I refuse to receive blood products.
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My body's structure allows safe access for certain medical procedures.
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I have kidney problems or am on dialysis.
Select...
I have severe valve leakage or narrowing besides the main one.
Select...
I had a heart attack within the last 30 days.
Select...
My blood vessels in the hip area are not suitable for safe medical device insertion.
Select...
I cannot take blood thinners during or after my valve surgery.
Select...
I have not had emergency surgery in the last 30 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke
Secondary study objectives
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Mean gradient
New York Heart Association (NYHA) Classification
+2 moreAwards & 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: TAVR - Failing surgical or transcatheter valveExperimental Treatment1 Intervention
Patients with a failing surgical or transcatheter bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR).
Find a Location
Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
182 Previous Clinical Trials
62,983 Total Patients Enrolled
Chris S Malaisrie, MDPrincipal InvestigatorNorthwestern University Feinberg School of Medicine
Mayra Guerrero, MDPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
1,188 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't needed heart or lung support machines in the last 30 days.Your heart imaging shows a mass, blood clot, or infection.I have a thickened heart muscle that obstructs blood flow.I have had a heart procedure with a permanent implant in the last 30 days, but not a pacemaker or defibrillator.I am scheduled for a procedure to treat Atrial Fibrillation.I have a surgical or transcatheter valve in my heart's mitral position.I have a heart condition that hasn't been treated with surgery.I have a history of blood disorders or abnormal bleeding.My heart's pumping ability is severely reduced.I refuse to receive blood products.I have not had a serious heart infection in the last 6 months.I have not had a stroke or mini-stroke in the last 3 months.My heart valve replacement is not working well, showing significant narrowing or leakage.My heart valve replacement is between 18.5 mm and 28.5 mm in size.My body's structure allows safe access to my heart's main artery.I have a surgery or heart-related procedure planned within the next 30 days.My body's structure allows safe access for certain medical procedures.A heart valve has a moderate or severe leakage problem.You are allergic to iodinated contrast and cannot be treated before the procedure.You are a woman capable of having a baby and your pregnancy test is positive.You have a higher chance of getting blocked arteries due to artificial valve leaflets.You are not expected to live more than 24 months.I have symptoms from narrowed neck arteries or had treatment for it within the last month.I have kidney problems or am on dialysis.You have a specific type of heart valve that has a high pressure difference after it was implanted.My heart valve replacement is not working properly.A group of heart experts believes the patient has a low to medium risk.The Heart Team has determined that you are likely to benefit from a valve implantation procedure.The faulty valve is not stable, wobbly, or damaged.I have severe valve leakage or narrowing besides the main one.A team of heart doctors thinks the patient has a low to medium risk.I had a heart attack within the last 30 days.My blood vessels in the hip area are not suitable for safe medical device insertion.I cannot take blood thinners during or after my valve surgery.You have heart-related symptoms that are moderate to severe.I have not had emergency surgery in the last 30 days.High risk of blood clotting around the transcatheter heart valve.I have some limitations on physical activity due to heart problems.
Research Study Groups:
This trial has the following groups:- Group 1: TAVR - Failing surgical or 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.
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