ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement (NCT03735667)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (31 items).
Location: University of Alabama at Birmingham — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- EC1. Subject has a unicuspid or bicuspid aortic valve.
- EC2. Subject has had an acute myocardial infarction within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation).
- EC3. Subject has had a cerebrovascular accident or transient ischemic attack clinically confirmed by a neurologist or neuroimaging within the past 6 months prior to study enrollment.
- EC4. Subject is on renal replacement therapy or has eGFR \<20.
- EC5. Subject has a pre-existing prosthetic aortic or mitral valve.
- EC6. Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.
- EC7. Subject has moderate or severe mitral stenosis (mitral valve area ≤1.5 cm2 and diastolic pressure half-time ≥150 ms, Stage C or D76).
- EC8. Subject has a need for emergency surgery for any reason.
- EC9. Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis.
- EC10. Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention.
- EC11. Subject has platelet count \<50,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<1,000 cells/mm3.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (75 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
- Banner Good Samaritan — Phoenix, Arizona
- HonorHealth Scottsdale Healthcare — Scottsdale, Arizona
- TMC HealthCare — Tucson, Arizona
- Baptist Health Medical Center — Little Rock, Arkansas
- Scripps Clinic — La Jolla, California
- Kaiser Permanente Los Angeles — Los Angeles, California
- Cedars-Sinai Heart Institute — Los Angeles, California
- University of California, Davis Medical Center — Sacramento, California
- Kaiser Permanente - San Francisco — San Francisco, California
- Stanford University Medical Center — Stanford, California
- MedStar Washington Hospital Center — Washington D.C., District of Columbia
- Morton Plant Hospital — Clearwater, Florida
- Orlando Regional Medical Center — Orlando, Florida
- Piedmont Hospital — Atlanta, Georgia
- Endeavor Glenbrook Hospital — Glenview, Illinois
- Advocate Christ Medical Center — Oak Lawn, Illinois
- St. John's Hospital (Prairie) — Springfield, Illinois
- St. Vincent's Hospital — Indianapolis, Indiana
- University of Iowa — Iowa City, Iowa
- Union Memorial Hospital — Baltimore, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts
- University of Massachusetts — Worcester, Massachusetts
- University of Michigan — Ann Arbor, Michigan
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.