REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects

To evaluate safety and effectiveness of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Sets for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe aortic stenosis who are considered at intermediate risk for surgical valve replacement including those who have a bicuspid native valve.

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

Wayne Batchelor, MD

Eric Sarin, MD

• Subject has documented severe aortic stenosis defined as initial AVA ≤ 1.0 cm2 (or AVA index ≤ 0.6 cm2/m2) AND a mean pressure gradient ≥ 40 mm Hg OR maximal aortic valve velocity ≥ 4.0 m/s OR Doppler velocity index ≤ 0.25 as measured by echocardiography and/or invasive hemodynamics
• Subject has a documented aortic annulus size of ≥ 20 mm and ≤ 27 mm
• Subject has symptomatic aortic valve stenosis with NYHA Functional Class ≥ II
• Heart team agrees that the subject is at intermediate risk of operative mortality

• Subject has a unicuspid or bicuspid aortic valve
• Subject has had an acute myocardial infarction within 30 days prior to the index procedure
• Subject has had a cerebrovascular accident or transient ischemic attack
• Subject is on renal replacement therapy or has GFR < 20
• Subject has a pre-existing prosthetic aortic or mitral valve
• Subject has severe (4+) aortic, tricuspid, or mitral regurgitation
• Subject has moderate to severe mitral stenosis
• Subject has a history of endocarditis within 6 months of index procedure
• Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention