The goal of the ACURATE IDE Clinical trial is to evaluate the safety and effectiveness of the transfemoral ACURATE™ Aortic Valve Platform for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
For more information, or to find out if you're an appropriate candidate for the ACURATE IDE clinical trial, download the ACURATE Valve TAVR Guide below, and bring it to a scheduled appointment with your heart doctor.
To see the full and updated list of clinical sites participating in the trial, visit the ACURATE IDE page on ClinicalTrials.gov.
Once the device is placed and the access site is healed, you will not feel the device. If you feel anything abnormal, please contact your study doctor.
Will the valve cause problems with metal detectors or interfere with future X-ray procedures?
No, the device will not set off a metal detector. The device is visible on X-ray but will not hamper the ability to perform future medical imaging procedures. However, you should notify your doctor that you have an artificial valve, especially before you have X-rays, CT scans, or MRI scans.
How often should I see my doctor?
Your study doctor will tell you how often you need to be seen and explain any special symptoms you should look for.
Is the ACURATE Valve device sterile?
Yes, the artificial valve is not a live tissue implant. The valve has been processed and sterilized prior to being placed into the body.
Will the ACURATE Valve device rust?
No, the device is made from a special medical-grade alloy that will not rust.
Can the ACURATE Valve device crush, bend, or move out of place?