Last updated on August 2019

ACURATE IDE: Safety and Efficacy Study of Acurate Valve for Transcatheter Aortic Valve Replacement

Brief description of study

To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.

Detailed Study Description

Subjects will be enrolled at up to 50 centers in the United States and Canada. There will be up to 600 subjects in ACURATE IDE.

The ACURATE IDE study cohorts include the following.

  • Randomized Cohort: A prospective, multicenter, 1:1 randomized controlled trial (RCT; ACURATE versus a commercially available balloon-expandable SAPIEN 3 Transcatheter Heart Valve or future iteration [SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA] or a commercially available self-expanding CoreValve Transcatheter Aortic Valve Replacement System, CoreValve Evolut R Recapturable TAVR System, EVOLUT PRO System, or future iteration [CoreValve; Medtronic, Inc., Dublin, Ireland]). There will be up to 500 subjects in the RCT.
  • Roll-In Cohort: A non-randomized roll-in phase with the test device. Centers that do not have implantation experience with the ACURATE neo Aortic Bioprosthesis (transfemoral delivery; Symetis SA, Ecublens, Switzerland) will perform at least 2 roll-in cases before commencing enrollment in the randomized cohort. Centers with prior experience with ACURATE are not required to do roll-in cases. Data from roll-in subjects will be summarized separately from the randomized cohort and will not be included in the primary endpoint analysis.

All subjects implanted will be followed at baseline, peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and then annually for up to 5 years post-procedure. Enrolled subjects who do not have a study device implanted will be assessed through 1-year post-procedure for safety/adverse events.

Clinical Study Identifier: NCT03735667

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Banner Good Samaritan

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Scripps Clinic

La Jolla, CA United States
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Cedars-Sinai Heart Institute

Los Angeles, CA United States
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San Francisco, CA United States
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Minneapolis, MN United States
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Saint Paul, MN United States
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Saint Louis, MO United States
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New Brunswick, NJ United States
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Albany, NY United States
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New York, NY United States
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University of North Carolina

Chapel Hill, NC United States
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Charlotte, NC United States
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Cleveland Clinic

Cleveland, OH United States
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Wormleysburg, PA United States
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Wynnewood, PA United States
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St Thomas Ascension

Nashville, TN United States
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