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

Division(s)

Research Type

Contact Information

Melissa Enlow, RN, MSN
412-647-1582
enlowms@upmc.edu

Eligibility

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)

For more information, visit the ClinicalTrials.gov link.