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NCT03735667 · ClinicalTrials.gov registry record · NA

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

A NA study of Aortic Stenosis, sponsored by Boston Scientific Corporation.

Active
Registry status
NA
Development phase
1,948
Enrollment target
20
Study locations

NCT03735667: Active NA study of Aortic Stenosis, sponsored by Boston Scientific Corporation.

NCT03735667 is a NA study of Aortic Stenosis that is active but no longer recruiting, run by Boston Scientific Corporation. The registered enrollment target is 1,948 participants, above the 1,287-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (51% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03735667, a NA study of Aortic Stenosis, is active but no longer recruiting, sponsored by Boston Scientific Corporation.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
1,948 participants
Enrollment target
20
Study locations

Study Summary

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.

Primary Outcome

Primary Endpoint: A Clinical Events Committee (CEC), independent group of physician experts reviewed and adjudicated all reported cases of death, stroke and rehospitalization to determine whether they met the specific protocol definition of the event. The CEC adjudicated results are used in the endpoint analysis. \* Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV); per VARC-2 definition.

Conditions Studied

Aortic Stenosis

Interventions

  • DEVICE ACURATE neo2™ Transfemoral TAVR System
  • DEVICE Medtronic CoreValve TAVR System
  • DEVICE Edwards SAPIEN 3 TAVR System
  • DEVICE ACURATE Prime™ Transfemoral TAVR System XL

Study Locations (20)

California

  • Scripps Clinic - La Jolla
  • Kaiser Permanente Los Angeles - Los Angeles
  • Cedars-Sinai Heart Institute - Los Angeles
  • University of California, Davis Medical Center - Sacramento
  • Kaiser Permanente - San Francisco - San Francisco
  • Stanford University Medical Center - Stanford

Arizona

  • Banner Good Samaritan - Phoenix
  • HonorHealth Scottsdale Healthcare - Scottsdale
  • TMC HealthCare - Tucson

Illinois

  • NorthShore University Health Study Coordinator - Evanston
  • Advocate Christ Medical Center - Oak Lawn
  • St. John's Hospital (Prairie) - Springfield

Florida

  • Morton Plant Hospital - Clearwater
  • Orlando Regional Medical Center - Orlando

Alabama

  • University of Alabama at Birmingham - Birmingham

Arkansas

  • Baptist Health Medical Center - Little Rock

District of Columbia

  • MedStar Washington Hospital Center - Washington D.C.

Georgia

  • Piedmont Hospital - Atlanta

Trial Details

FieldValue
Enrollment Target 1,948 participants
Start Date 2019-06-10
Est. Completion 2029-09
Phase NA
Boston Scientific Corporation

280 total trials

What the registry record for NCT03735667 still lists

NCT03735667 is an interventional study that assigns participants to a tested intervention. Its 1,948 participants enrollment target places it among the larger protocols in the corpus, above the 1,287-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (51% higher).

The record links to 1 condition, with Aortic Stenosis appearing as the primary indexed condition, and to 4 interventions - of which ACURATE neo2™ Transfemoral TAVR System is the first listed.

NCT03735667 names 20 study sites across 10 states, led by California, Arizona, Illinois.

Frequently Asked Questions

What is clinical trial NCT03735667 about?

NCT03735667 is a clinical study titled "ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement". 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 dis...

What is the current status of trial NCT03735667?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,948 participants. The study started on 2019-06-10. Estimated completion is 2029-09.

What conditions does trial NCT03735667 study?

This clinical trial studies the following conditions: Aortic Stenosis.

What interventions are being tested in trial NCT03735667?

The interventions under investigation include: ACURATE neo2™ Transfemoral TAVR System (DEVICE), Medtronic CoreValve TAVR System (DEVICE), Edwards SAPIEN 3 TAVR System (DEVICE), ACURATE Prime™ Transfemoral TAVR System XL (DEVICE).

Who is sponsoring clinical trial NCT03735667?

This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03735667 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Aortic Stenosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03735667's enrollment target sits among peer trials

1,948 5th of 26 higher than 22 of 26 other Aortic Stenosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Aortic Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03735667, the US trial registry maintained by the National Library of Medicine. NCT03735667 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.