ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement (NCT03735667)
ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve Through Implantation of ACURATE in Subjects InDicatEd for TAVR
🩺 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: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (75 Sites)
Showing the first 25 of 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.
More studies in Aortic Stenosis
- PERIGON Pivotal Trial — Los Angeles, California
- PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis — Birmingham, Alabama
- Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study — Tucson, Arizona
- Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study) — Edmonton, Alberta
- Systematic Ambulatory ECG Monitoring Following TAVI — Québec, Quebec
Explore by condition: All Aortic Stenosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.