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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
P3-AVIV Trial 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.Check my eligibility
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.See study design
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.
P3-AVIV Trial 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.
Select...
My heart valve replacement is not working properly.
Select...
I have some limitations on physical activity due to heart problems.
P3-AVIV Trial 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 - Non-hierarchical composite of all-cause mortality and stroke
Secondary outcome measures
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Mean gradient
New York Heart Association (NYHA) Classification
+2 moreP3-AVIV 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).
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Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
61,449 Total Patients Enrolled
Chris S Malaisrie, MDPrincipal InvestigatorNorthwestern University Feinberg School of Medicine
Alan Zajarias, MDPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
53 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have signed up to participate in this clinical trial?
"Edwards Lifesciences is running the trial at two sites, University of Pennsylvania Hospital in Philadelphia and Washington University/ Barnes-Jewish Hospital in Saint Louis. To reach statistical significance, a total of 125 eligible participants must be enrolled."
Answered by AI
How many healthcare facilities are engaged in this examination?
"The present medical trial is being carried out across 36 different sites, with a particular focus on cities such as Philadelphia, Saint Louis and Murray. To reduce the burden of travel for participants it's important to select the closest clinic available."
Answered by AI
Is this medical research accepting participants currently?
"Affirmative. According to clinicaltrials.gov, this research is actively recruiting individuals with 125 participants being sought from 33 distinct medical institutions since the study's inception on May 1st 2017 and its most recent edit in April 6th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
The University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Met criteria
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