Your session is about to expire
← Back to Search
TAVR with CENTERA THV for Aortic Stenosis
Study Summary
This trial will test the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with severe aortic valve stenosis who are at intermediate risk for surgical aortic valve replacement (SAVR).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I have not had a serious heart infection in the last 6 months.The medical team has assessed that you are very weak and may not be able to handle the treatment.My aortic valve is either one-flap, two-flap, or not hardened by calcium.My blood vessels in the hip area are not suitable for safe medical device insertion.I have had recent treatment for narrowed neck arteries or have symptoms of it.I have severe lung disease or need home oxygen.I have severe high blood pressure in the lungs.I haven't needed heart or lung support machines in the last 30 days.The doctors estimate that you may have less than 2 years to live.You have heart failure that affects your ability to do daily activities.My heart team considers me at intermediate risk for open heart surgery.My heart valve size does not fit the 23, 26, or 29 mm valve sizes.I have severe leaking or moderate blockage in my heart's mitral valve.I cannot take blood thinning medication during or after my valve surgery.I have severe, calcified aortic stenosis.My heart's pumping ability is significantly reduced.I have a thickened heart muscle that obstructs blood flow.I refuse to receive blood transfusions.I had a heart attack less than 30 days before my planned valve surgery.I am scheduled for a procedure to treat irregular heartbeat.I have not had a stroke or mini-stroke in the last 90 days.You weigh more than 110 pounds for every 4 feet of your height.I have a history of blood disorders or abnormal bleeding.There is a visible abnormality in your heart on imaging that could affect the study.You have a strong allergy to the dye used in certain medical tests that cannot be managed with medication before the test.I can move enough to complete study tasks.Women who can have children have a positive pregnancy test.My heart's structure increases the risk of artery blockage after a valve replacement.I have complex heart artery disease.I do not have major aortic disease that would make surgery unsafe.I have a history of cirrhosis or currently have liver disease.You are allergic to nickel or titanium.I have kidney problems or am on dialysis.You have a serious problem with the aortic valve in your heart.You have a mechanical or bioprosthetic valve in your heart.
- Group 1: Transcatheter Aortic Valve Replacement (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
How many medical facilities are offering the opportunity to participate in this trial?
"This clinical trial is presently enrolling from 23 distinct medical centres. These locations range from Boston to Kansas City while also featuring sites in Washington and beyond. To reduce travel burden, it is important to select the location closest to you when participating."
Are there any opportunities currently open to participate in the experiment?
"The trial, which was initially posted on September 18th 2018 and last modified October 7th 2022, is not enrolling patients at this time. However, 307 other medical trials are currently accepting participants."
Share this study with friends
Copy Link
Messenger