Purpose

The purpose of this study is to evaluate the safety and efficacy of the Medtronic CoreValve System in the treatment of symptomatic severe aortic stenosis in research participants who are at high risk for aortic valve surgery.

High-risk surgical research participants will be randomized to receive either transcatheter aortic valve implant (TAVI) with the Medtronic CoreValve System (MCS) or standard aortic valve replacement surgery.

Eligibility Requirements

• The patient must have severe degenerative aortic valve disease such that one cardiologist and two cardiac surgeons agree the patient is at risk for aortic valve replacement surgery.
• The patient is symptomatic from his or her aortic valve stenosis.
• The patient has provided written informed consent.
• The patient and the treating physician agree that the patient will return for all required post-procedure follow-up.

For more information, call 888-HRT-DUKE (888-478-3853) or 919-681-5816. After the automated voice, please select "2" and listen to the prompts. You may also e-mail corevalve@dm.duke.edu.