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Ensaio clínico

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

NCT: NCT03735667 · ACTIVE_NOT_RECRUITING

ID NCTNCT03735667
EstadoACTIVE_NOT_RECRUITING
Data de início2019-06-10
SponsorBoston Scientific Corporation (INDUSTRY)
First posted
Last updated

Resumo breve

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. As of 28-May-2025, Boston Scientific Corporation (BSC) announced the voluntary global discontinuation of the ACURATE product platform, including both the ACURATE neo2 and ACURATE Prime Aortic Valve Systems. BSC will no longer pursue regulatory approval for the device in the U.S. or other unapproved geographies.

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