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(REPRISE III): Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement

General Information

Age Group

Adult

Status

Active

Protocol Number

NCT02202434

Background Information

The objective of this study is to evaluate the safety and effectiveness of the Lotus™ valve system for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement.

Device: Lotus transcatheter aortic valve and delivery system vs. CoreValve transcatheter aortic valve replacement system for severe aortic stenosis

Offered At

Inova Heart and Vascular Institute
3300 Gallows Road
Falls Church, VA  22042
 

Principal Investigator

Shahram Yazdani, MD

Eligibility Information

  • 18 years and older
  • Severe native aortic stenosis with an initial aortic valve area (AVA) of ≤1.0 cm2 (or AVA index of ≤0.6 cm2/m2) and a mean pressure gradient >40 mm Hg or jet velocity >4.0 m/s
  • Symptomatic aortic valve stenosis with New York Heart Association (NYHA) functional class ≥ II
  • Society of Thoracic Surgeons (STS) score ≥8%

Ineligibility Information

  • Congenital unicuspid or bicuspid aortic valve
  • Subject requires chronic anticoagulation therapy after the implant procedure and cannot be treated with warfarin (other anticoagulants are not permitted in the first month) for at least 1 month concomitant with either aspirin or clopidogrel
  • No MI < 30 days, CVA < 6 months, severe renal disease

For more information, go to https://clinicaltrials.gov/ct2/show/NCT02202434?term=Reprise&rank=3