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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

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

S2354

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