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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 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.
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 1,948 participants |
| Start Date | 2019-06-10 |
| Est. Completion | 2029-09 |
| Phase | NA |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 1,948 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,287-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (51% higher). The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.
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Related
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