ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
Public ClinicalTrials.gov record NCT03735667. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve Through Implantation of ACURATE in Subjects InDicatEd for TAVR
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03735667
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,948 participants
Conditions and interventions
Conditions
Interventions
- ACURATE neo2™ Transfemoral TAVR System Device
- Medtronic CoreValve TAVR System Device
- Edwards SAPIEN 3 TAVR System Device
- ACURATE Prime™ Transfemoral TAVR System XL Device
Device
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 10, 2019 (Actual)
- Primary completion
- Jun 14, 2024 (Actual)
- Completion
- Sep 2029 (Estimated)
- Last update posted
- Sep 16, 2026
2019 – 2029
United States locations
- U.S. sites
- 69
- U.S. states
- 28
- U.S. cities
- 61
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Banner Good Samaritan | Phoenix | Arizona | 85006 | — |
| HonorHealth Scottsdale Healthcare | Scottsdale | Arizona | 85260 | — |
| TMC HealthCare | Tucson | Arizona | 85712 | — |
| Baptist Health Medical Center | Little Rock | Arkansas | 72205 | — |
| Scripps Clinic | La Jolla | California | 92037 | — |
| Kaiser Permanente Los Angeles | Los Angeles | California | 90027 | — |
| Cedars-Sinai Heart Institute | Los Angeles | California | 90048 | — |
| University of California, Davis Medical Center | Sacramento | California | 95817 | — |
| Kaiser Permanente - San Francisco | San Francisco | California | 94115 | — |
| Stanford University Medical Center | Stanford | California | 94305 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Morton Plant Hospital | Clearwater | Florida | 33756 | — |
| Orlando Regional Medical Center | Orlando | Florida | 32806 | — |
| Piedmont Hospital | Atlanta | Georgia | 30309 | — |
| Endeavor Glenbrook Hospital | Glenview | Illinois | 60026 | — |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | — |
| St. John's Hospital (Prairie) | Springfield | Illinois | 62769 | — |
| St. Vincent's Hospital | Indianapolis | Indiana | 46290 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Union Memorial Hospital | Baltimore | Maryland | 21218 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| University of Massachusetts | Worcester | Massachusetts | 01655 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| CentraCare Heart and Vascular Center | Saint Cloud | Minnesota | 56303 | — |
| St. Joseph's Hospital-St. Paul | Saint Paul | Minnesota | 55102 | — |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | — |
| Englewood Health | Englewood | New Jersey | 07631 | — |
| Robert Wood Johnson Medical Center | New Brunswick | New Jersey | 08901 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| Kaleida Health | Buffalo | New York | 14203 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Columbia University Medical Center/NYPH | New York | New York | 10032 | — |
| Cornell Presbyterian - New York | New York | New York | 10065 | — |
| Montefiore-Jack D. Weiler Hospital | The Bronx | New York | 10461 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | — |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | — |
| Lindner Center for Research and Education at Christ Hospital | Cincinnati | Ohio | 45219 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| OhioHealth Research and Innovation Institute | Columbus | Ohio | 43214 | — |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | — |
| Providence Heart Institute | Portland | Oregon | 97225 | — |
| Sacred Heart Medical Center - Riverbend | Springfield | Oregon | 97477 | — |
| UPMC - Pinnacle | Harrisburg | Pennsylvania | 17101 | — |
| UPMC Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Lankenau | Wynnewood | Pennsylvania | 19086 | — |
| WellSpan York Hospital | York | Pennsylvania | 17403 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Lexington Medical Center | West Columbia | South Carolina | 29169 | — |
| St Thomas Ascension | Nashville | Tennessee | 37205 | — |
| Austin Heart | Austin | Texas | 78705 | — |
| Baylor Heart and Vascular Hospital | Dallas | Texas | 75226 | — |
| Presbyterian Hospital of Dallas | Dallas | Texas | 75231 | — |
| The Methodist Hospital Research Institute | Houston | Texas | 77030 | — |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| Baylor Regional Medical Center at Plano | Plano | Texas | 75093 | — |
| Methodist Healthcare System of San Antonio dba Methodist Hospital | San Antonio | Texas | 78229 | — |
| The University of Vermont Medical Center | Burlington | Vermont | 05401 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| Providence Regional Medical Center | Everett | Washington | 98201 | — |
| Bellin Health | Green Bay | Wisconsin | 54301 | — |
| Aurora Research Institute | Milwaukee | Wisconsin | 53024 | — |
| Medical College of Wisconsin - Froedtert Hospital | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03735667, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 16, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03735667 live on ClinicalTrials.gov.