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TAVR for Aortic Stenosis (EARLY TAVR Trial)
EARLY TAVR Trial Summary
This trial will compare the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve to standard clinical surveillance in patients with severe, calcific aortic stenosis who are not experiencing symptoms.
EARLY TAVR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEARLY TAVR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.EARLY TAVR Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with severe narrowing of the aortic valve.You have a serious problem with a heart valve called the aortic valve.I haven't needed heart or lung support machines in the last 30 days.You have a pre-existing mechanical or bioprosthetic heart valve.Your doctor thinks you have less than 2 years to live.I have not had a stroke or mini-stroke in the last 3 months.I have not had a serious heart infection in the last 6 months.I am experiencing symptoms.You have evidence of a mass or blood clot inside your heart based on a heart imaging test.I do not have any symptoms.Your body mass index (BMI) is over 50, which means you are very overweight.My heart surgery risk score is 10 or less.I need heart valve surgery due to my heart condition.My aortic valve is abnormal and not suitable for a specific heart valve procedure.I have severe leaking or significant narrowing of my mitral heart valve.I cannot take blood thinning medications due to my condition.My heart has a calcification that could risk complications after a valve replacement.I am 65 years old or older.I have severe lung disease or need home oxygen.I do not have major aortic disease that would make surgery unsafe.I refuse to receive blood products.I am allergic to iodine-based contrast and cannot be treated with pre-medication.I currently have or had COVID-19 with lasting effects.Your aortic valve size is not suitable for the available replacement options.I have kidney problems or am on dialysis.I have a blood disorder affecting my white cells, red cells, or platelets.My blood vessels in the hip area are not suitable for safe medical device insertion.I have had symptoms or treatment for narrowed neck arteries within the last month.I had a heart attack less than 30 days ago.The medical team thinks you are very weak.Your heart is pumping blood normally.I have a history of cirrhosis or another active liver disease.I have severe high blood pressure in the lungs.I have a thickened heart muscle that obstructs blood flow.
- Group 1: CS
- Group 2: TAVR
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What goals is this research endeavor looking to accomplish?
"Edwards Lifesciences, the trial sponsor, has set a two-year timeline for assessing the primary outcome of all-cause death, strokes, and unplanned cardiovascular hospitalization. Furthermore, secondary results such as mortality or disabling stroke rate, average change in Left Ventricular Ejection Fraction (LVEF) from baseline numbers, and composite scores that factor living status with Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥75 and decrease ≤10 points will be monitored."
How many medical centers have agreed to participate in this trial?
"Several locations are administering this research, including the University of Florida in Gainesville and UC Health Northern Colorado (Medical Center of the Rockies) in Loveland. Additionally, Huntington Hospital in Pasadena is one of 77 other sites taking part."
Is this medical trial open to enrollment at the moment?
"According to clinicaltrials.gov, the trial is not presently admitting candidates. The first posting was on July 12th 2017 and the most recent update occurred on January 21st 2022. Nevertheless, there are an additional 619 studies actively enrolling individuals as of right now."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
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