CoreValve® U.S. Expanded Use
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
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)
For more information, visit the ClinicalTrials.gov link.