CoreValve® U.S. Expanded Use

Full Title

Medtronic CoreValve® U.S. Expanded Use Study

Purpose of Study

The purpose of this clinical study is to determine if replacing the aortic valve without open-heart surgery in patients that are outside the normal inclusion criteria (ESRD, low flow, low gradient, pre-existing prosthetic valve) is as safe or safer than open-heart surgery in patients with similar medical conditions.

Sponsor: Medtronic, Inc.
Local Principal Investigators: Thomas G. Gleason, MD and Joon Sup Lee, MD


Research Type

Contact Information

Melissa Enlow, RN, MSN


Subjects with symptomatic severe aortic stenosis requiring aortic valve replacement, with predicted operative mortality or serious, irreversible morbidity risk of ≥ 50% at 30 days, and at least one of the following conditions:

  • Severe (≥3-4+) mitral valve regurgitation
  • Severe (≥3-4+) tricuspid valve regurgitation
  • End stage renal disease (ESRD) requiring renal replacement therapy
  • Low gradient, low output aortic stenosis
  • Failed bioprosthetic surgical aortic valve
  • 2 or more conditions (listed above)

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