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ACTIVE NOT RECRUITING NA

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

NCT03735667 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

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

Sponsor

Boston Scientific Corporation

120 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03735667

The ClinicalTrials.gov registry entry for NCT03735667 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,948 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 120 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03735667 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Arizona, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03735667?

This trial is sponsored by Boston Scientific Corporation, which has 120 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial