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

Active, not recruiting · Not applicable · NCT03735667

Conditions: Aortic Stenosis

At a glance

Research payments reported, 2025
$3.1M
U.S. investigators named
72
Sites paid
72
Planned or actual enrollment
1,948

About the trial

Sponsor
Boston Scientific Corporation
Tested
ACURATE neo2™ Transfemoral TAVR System (device), Medtronic CoreValve TAVR System (device), Edwards SAPIEN 3 TAVR System (device), ACURATE Prime™ Transfemoral TAVR System XL (device)
Dates
Started 2019-06-10; completion 2029-09
Results posted
Yes

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.

From ClinicalTrials.gov, last updated 2026-09-16. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Boston Scientific Corporation reported $3.1M in research payments for this study in 2025 (674 payments).

Products named: Clinical Trial Product

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.