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8110 Gatehouse Road, Falls Church, VA 22042

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


General Information

Age Group




Protocol Number


Background Information

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.

Offered At

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Wayne Batchelor, MD

Eric Sarin, MD

Eligibility Information

  • 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

Ineligibility Information

  • 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