Caution: Investigational device. Limited by United States law to investigational use.

The Clinical Trial

The clinical trial will involve more than 1,300 patients at up to 40 hospitals in the United States. Before taking part in the clinical trial, you will need to obtain and sign a consent form at one of the 40 U.S. hospitals in the trial.

If you take part in the trial, you may be assigned to receive one of two treatments:

  1. Open heart surgical aortic valve replacement More Information
  2. Transcatheter aortic valve implantation More Information

Depending on your condition, you may be put in a treatment group that will be randomized.

Here’s how it works:

How it works

Open Heart, Surgical Aortic Valve Replacement

Open heart aortic valve replacement surgery is an effective, life-saving treatment option for certain people with severe aortic stenosis. With open heart aortic valve replacement, your chest is opened to allow the surgeon access to your heart.

The operation varies from patient to patient, lasting about two hours and often longer. You are asleep for the operation. During the operation, the surgeon will remove any tissue and calcium deposits that are affecting the normal function of the valve. Your damaged valve may be completely removed. Then, the new valve will be sewn into the space where your own valve used to be. After the surgeon makes sure your valve is working properly, your heart will begin to pump blood and your chest will be closed.

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Transcatheter Aortic Valve Implantation

Transcatheter aortic valve implantation using the device being studied is only available through the clinical trial. With transcatheter aortic valve implantation, an artificial aortic heart valve attached to a wire frame is guided by catheter (thin, flexible tube) to the heart. Once in the proper position in the heart, the wire frame expands, allowing the new aortic valve to open and begin to pump blood.

Learn more about the investigational therapy. To see if you may qualify for this clinical trial, please take this short survey or connect with a participating doctor. Talk with your doctor about potential risks associated with transcatheter aortic valve implantation.

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