REPRISE IV: REpositionable Percutaneous Replacement of StenoticAortic Valve through Implantation of LOTUS Edge Valve System inIntermediatE Surgical Risk Subjects
Sponsor: |
Boston Scientific Corporation |
Enrolling: |
Male and Female Patients |
Study Length: |
10 Years |
IRB Number: |
AAAS2245 |
U.S. Govt. ID: |
NCT03618095 |
Contact: |
Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu |
The LOTUS Edge Valve System is intended to improve aortic valve function in symptomatic subjects with severe aortic stenosis who are at intermediate risk for standard surgical aortic valve replacement (SAVR), including those who have a bicuspid native valve. The study will include subjects presenting with symptomatic severe aortic stenosis who are considered at intermediate risk for surgical valve replacement, including those who have a bicuspid native valve.
This study is closed
Investigator
Susheel Kodali, MD
Are you 18 years of age or older? |
Yes |
No |