ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
AI Description
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
- child, adult, older adult
- Participants
- 1948
- Expected completion
- 2029-09
- Funded by
- industry
Conditions studied
Aortic Stenosis
What is being tested
- DEVICE: ACURATE Prime™ Transfemoral TAVR System XL
- DEVICE: ACURATE neo2™ Transfemoral TAVR System
- DEVICE: Edwards SAPIEN 3 TAVR System
- DEVICE: Medtronic CoreValve TAVR System
What it measures
- Composite Rate of All-cause Mortality, All Stroke, and Rehospitalization* at 1 Year in the Main Randomized Cohort., Primary Endpoint: A Clinical Events Committee (CEC), independent group of physician experts reviewed and adjudicated all reported cases of death, stroke and rehospitalization to determine whether they met the specific protocol definition of the event. The CEC adjudicated results are used in the endpoint analysis. \* Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV); per VARC-2 definition., Participants will be followed for the duration of hospital stay through 1 year.
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Abbott Northwestern Hospital
Minneapolis, MN
Advocate Christ Medical Center (Oak Lawn)
Oak Lawn, IL
Albany Medical Center
Albany, NY
Ascension Saint Thomas Hospital
Nashville, TN
Ascension Seton Medical Center Austin
Austin, TX
Ascension St. Vincent Heart Center
Carmel, IN
Atrium Health Carolinas Medical Center
Charlotte, NC
Atrium Health Wake Forest Baptist Medical Center
Winston-salem, NC
Banner – University Medical Center Phoenix
Phoenix, AZ
Baptist Health Medical Center-Little Rock
Little Rock, AR
Baylor Scott & White The Heart Hospital – Dallas
Dallas, TX
Baylor Scott & White The Heart Hospital – Plano
Plano, TX
Bellin Memorial Hospital
Green Bay, WI
Brigham and Women's Hospital
Boston, MA
Cedars-Sinai Medical Center
Los Angeles, CA
CentraCare – St. Cloud Hospital
Saint Cloud, MN
Cleveland Clinic
Cleveland, OH
Deborah Heart & Lung Center
Browns Mills, NJ
Englewood Hospital
Englewood, NJ
Froedtert Hospital
Milwaukee, WI
Henry Ford Health (Detroit)
Detroit, MI
HonorHealth Scottsdale Shea Medical Center
Scottsdale, AZ
Houston Methodist Hospital
Houston, TX
HSHS St. John's Hospital
Springfield, IL
INTEGRIS Health Heart Hospital at Baptist Medical Center
Oklahoma City, OK
Kaiser Permanente Los Angeles Medical Center
Los Angeles, CA
Kaiser Permanente San Francisco Medical Center
San Francisco, CA
Kaleida Health
Buffalo, NY
Lankenau Medical Center
Wynnewood, PA
Lexington Medical Center
West Columbia, SC
Massachusetts General Hospital
Boston, MA
MedStar Union Memorial Hospital
Baltimore, MD
MedStar Washington Hospital Center
Washington, DC
Methodist Hospital
San Antonio, TX
Morton Plant Hospital (Clearwater)
Clearwater, FL
MUSC Health
Charleston, SC
NewYork-Presbyterian Hospital
New York, NY
OhioHealth Riverside Methodist Hospital
Columbus, OH
Orlando Health
Orlando, FL
PeaceHealth Sacred Heart Medical Center (RiverBend)
Springfield, OR
Piedmont Atlanta Hospital
Atlanta, GA
Providence Regional Medical Center Everett
Everett, WA
Providence St. Vincent Medical Center
Portland, OR
Robert Wood Johnson University Hospital
New Brunswick, NJ
Scripps Memorial Hospital La Jolla
La Jolla, CA
Sentara Norfolk General Hospital
Norfolk, VA
Stanford Health Care
Stanford, CA
Texas Health Dallas
Dallas, TX
The Christ Hospital
Cincinnati, OH
The Mount Sinai Hospital
New York, NY
The University of Vermont Medical Center
Burlington, VT
Tucson Medical Center
Tucson, AZ
UAB Hospital
Birmingham, AL
UC Davis Medical Center
Sacramento, CA
UMass Memorial Medical Center - University Campus
Worcester, MA
UNC Hospitals
Chapel Hill, NC
University Hospitals Cleveland Medical Center
Cleveland, OH
University Medical Center
Charlottesville, VA
University of Iowa Health Care
Iowa City, IA
University of Michigan Health System
Ann Arbor, MI
UPMC Harrisburg
Harrisburg, PA
UPMC Presbyterian Shadyside
Pittsburgh, PA
WellSpan York Hospital
York, PA
Registry entry updated 2026-09-16
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.