REPRISE IV: REpositionable Percutaneous Replacement of StenoticAortic Valve through Implantation of LOTUS Edge Valve System inIntermediatE Surgical Risk Subjects
REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects (REPRISE IV)
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
Additional Study Information: 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
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For more information, please contact:
Kate Dalton
keb2114@cumc.columbia.edu
347-514-3366