ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement

NCT03735667 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: S2408
• Study Type: interventional
• Target: 1,948
• Locations: 2 countries
• Sites: 75

Brief 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

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• 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.

Other Outcomes (28)

• Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular

  Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.

• Rate of All Stroke: Disabling and Non-disabling

  Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.

• Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure)

  Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.

Study Arms (7)

ACURATE Valve - Main Randomized

EXPERIMENTAL

Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. \*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.

Device: ACURATE neo2™ Transfemoral TAVR System

ACURATE Valve - Single-arm Roll-in

EXPERIMENTAL

Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.

Device: ACURATE neo2™ Transfemoral TAVR System

Commercial Valve - Main Randomized

ACTIVE COMPARATOR

Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. \*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Device: Medtronic CoreValve TAVR System; Device: Edwards SAPIEN 3 TAVR System

ACURATE Valve - Single-arm Prime XL

EXPERIMENTAL

Patients assigned to this group will be implanted with ACURATE Prime™ transfemoral TAVR System XL. \*50 subjects will be enrolled in the Prime™ XL Nested Registry

Device: ACURATE Prime™ Transfemoral TAVR System XL

ACURATE Valve - Extended Durability Randomized

EXPERIMENTAL

Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System (S, M, L) or ACURATE Prime™ transfemoral TAVR System XL. Only low risk patients are enrolled in this group.

Device: ACURATE neo2™ Transfemoral TAVR System; Device: ACURATE Prime™ Transfemoral TAVR System XL

Commercial Valve - Extended Durability Randomized

ACTIVE COMPARATOR

Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. Only low risk patients are enrolled in this group.

Device: Medtronic CoreValve TAVR System; Device: Edwards SAPIEN 3 TAVR System

ACURATE Valve - Continued Access Study

EXPERIMENTAL

Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System (S, M, L) or ACURATE Prime™ transfemoral TAVR System XL.

Device: ACURATE neo2™ Transfemoral TAVR System; Device: ACURATE Prime™ Transfemoral TAVR System XL

Interventions

ACURATE neo2™ Transfemoral TAVR System DEVICE

ACURATE neo2™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).

ACURATE Valve - Continued Access Study; ACURATE Valve - Extended Durability Randomized; ACURATE Valve - Main Randomized; ACURATE Valve - Single-arm Roll-in

Medtronic CoreValve TAVR System DEVICE

Medtronic CoreValve Evolut R or Evolut PRO Transcatheter Aortic Valve Replacement (TAVR) System (or any future Corevalve iterations): The support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. The bioprosthesis is manufactured by suturing valve leaflets and a skirt from porcine pericardium into a tri-leaflet configuration (manufactured by Medtronic CoreValve LLC, Santa Ana, USA).

Commercial Valve - Extended Durability Randomized; Commercial Valve - Main Randomized

Edwards SAPIEN 3 TAVR System DEVICE

Edwards SAPIEN 3 TAVR system (or any future SAPIEN iterations): balloon-expandable transcatheter aortic bioprosthesis, support frame made of cobalt-chromium, three leaflets constructed of processed bovine pericardial tissue and an outer polyethylene terephthalate (PET) sealing cuff to mitigate paravalvular regurgitation (manufactured by Edwards Lifesciences, Inc., Irvine, California, USA)

Commercial Valve - Extended Durability Randomized; Commercial Valve - Main Randomized

ACURATE Prime™ Transfemoral TAVR System XL DEVICE

ACURATE Prime™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).

ACURATE Valve - Continued Access Study; ACURATE Valve - Extended Durability Randomized; ACURATE Valve - Single-arm Prime XL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• IC1. Subject has documented severe symptomatic native aortic stenosis defined as follows: aortic valve area (AVA) ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2) AND a mean pressure gradient ≥40 mmHg, OR maximal aortic valve velocity ≥4.0 m/s, OR Doppler velocity index ≤0.25 as measured by echocardiography and/or invasive hemodynamics.
• Note: In cases of low flow, low gradient aortic stenosis with left ventricular dysfunction (ejection fraction \<50%), dobutamine can be used to assess the grade of aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min recommended); the subject may be enrolled if echocardiographic criteria are met with this augmentation.
• IC2. Subject has a documented aortic annulus size of ≥20.5 mm and ≤29 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee \[CRC\]) and, for the Main Randomized Cohort and the Extended Durability Study, is deemed treatable with an available size of both test and control device.
• IC3. For subjects with symptomatic aortic valve stenosis per IC1 definition above, functional status is NYHA Functional Class ≥ II.
• IC4. Heart team (which must include an experienced cardiac interventionalist and an experienced cardiac surgeon) agrees that the subject is indicated for TAVR, is likely to benefit from valve replacement, and TAVR is appropriate.
• IC5. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
• IC6. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.
• IC7. Subject is expected to be able to take the protocol-required adjunctive pharmacologic therapy.

You may not qualify if:

• 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.
• EC12. Subject has had a gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen, or will refuse transfusions.
• EC13. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to the protocol required medications (aspirin, all P2Y12 inhibitors, heparin), or to the individual components of the test or control valve (nickel, titanium, stainless steel, platinum, iridium or polyethylene terephthalate \[PET\]).
• EC14. Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment.
• EC15. Subject has hypertrophic cardiomyopathy.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (75)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Banner Good Samaritan

Phoenix, Arizona, 85006, United States

Location

HonorHealth Scottsdale Healthcare

Scottsdale, Arizona, 85260, United States

Location

TMC HealthCare

Tucson, Arizona, 85712, United States

Location

Baptist Health Medical Center

Little Rock, Arkansas, 72205, United States

Location

Scripps Clinic

La Jolla, California, 92037, United States

Location

Kaiser Permanente Los Angeles

Los Angeles, California, 90027, United States

Location

Cedars-Sinai Heart Institute

Los Angeles, California, 90048, United States

Location

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

Kaiser Permanente - San Francisco

San Francisco, California, 94115, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Endeavor Glenbrook Hospital

Glenview, Illinois, 60026, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

St. John's Hospital (Prairie)

Springfield, Illinois, 62769, United States

Location

St. Vincent's Hospital

Indianapolis, Indiana, 46290, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, 56303, United States

Location

St. Joseph's Hospital-St. Paul

Saint Paul, Minnesota, 55102, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Englewood Health

Englewood, New Jersey, 07631, United States

Location

Robert Wood Johnson Medical Center

New Brunswick, New Jersey, 08901, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Kaleida Health

Buffalo, New York, 14203, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

Cornell Presbyterian - New York

New York, New York, 10065, United States

Location

Montefiore-Jack D. Weiler Hospital

The Bronx, New York, 10461, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Lindner Center for Research and Education at Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

OhioHealth Research and Innovation Institute

Columbus, Ohio, 43214, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Providence Heart Institute

Portland, Oregon, 97225, United States

Location

Sacred Heart Medical Center - Riverbend

Springfield, Oregon, 97477, United States

Location

UPMC - Pinnacle

Harrisburg, Pennsylvania, 17101, United States

Location

UPMC Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Lankenau

Wynnewood, Pennsylvania, 19086, United States

Location

WellSpan York Hospital

York, Pennsylvania, 17403, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Lexington Medical Center

West Columbia, South Carolina, 29169, United States

Location

St Thomas Ascension

Nashville, Tennessee, 37205, United States

Location

Austin Heart

Austin, Texas, 78705, United States

Location

Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

Presbyterian Hospital of Dallas

Dallas, Texas, 75231, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Baylor Regional Medical Center at Plano

Plano, Texas, 75093, United States

Location

Methodist Healthcare System of San Antonio dba Methodist Hospital

San Antonio, Texas, 78229, United States

Location

The University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Providence Regional Medical Center

Everett, Washington, 98201, United States

Location

Bellin Health

Green Bay, Wisconsin, 54301, United States

Location

Aurora Research Institute

Milwaukee, Wisconsin, 53024, United States

Location

Medical College of Wisconsin - Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W5, Canada

Location

Providence Health - St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

London Health Sciences

London, Ontario, N6A 5A5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (2)

• Makkar RR, Chakravarty T, Gupta A, Soliman O, Gnall E, Ramana RK, Ramlawi B, Diamantouros P, Potluri S, Kleiman NS, Samy S, Rassi A, Yadav P, Thourani V, Yakubov S, Frawley C, Patel D, Kapadia S, Chalekian A, Modolo R, Sathananthan J, Kim WK, Reardon MJ. Valve Underexpansion and Clinical Outcomes With ACURATE neo2: Findings From the ACURATE IDE Trial. J Am Coll Cardiol. 2025 Jul 29;86(4):225-238. doi: 10.1016/j.jacc.2025.05.011. Epub 2025 May 21.

  PMID: 40406945 BACKGROUND

• Makkar RR, Ramana RK, Gnall E, Ramlawi B, Cheng W, Diamantouros P, Potluri S, Kleinman N, Gupta A, Chakravarty T, Samy S, Rassi A, Rajagopal V, Yakubov S, Sorajja P, Patel D, Garcia S, Yadav P, Thourani V, Wang J, Rinaldi M, Kapadia S, Waksman R, Webb J, Ren CB, Gregson J, Modolo R, Sathananthan J, Reardon MJ; ACURATE IDE study investigators. ACURATE neo2 valve versus commercially available transcatheter heart valves in patients with severe aortic stenosis (ACURATE IDE): a multicentre, randomised, controlled, non-inferiority trial. Lancet. 2025 Jun 7;405(10494):2061-2074. doi: 10.1016/S0140-6736(25)00319-8. Epub 2025 May 21.

  PMID: 40412426 RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Limitations and Caveats

Trial-related factors * First RCT experience with ACURATE neo2 enrolled patients of all risks * Control arm included two comparator devices, with operator selection of preferred Control at time of randomization Enrollment factors * COVID - impact on staffing resources (hospital \& sponsor support); supply constraints; investigational cases deprioritized relative to commercial cases * Operators less experienced with ACURATE neo2 compared to Control devices

Results Point of Contact

• Title: Sarah Zanon
• Organization: Boston Scientific

sarah.zanon@bsci.com

+41 79 840 7006

Study Officials

• Raj R. Makkar, MD

  Cedars-Sinai Heart Institute

  PRINCIPAL INVESTIGATOR

• Michael J. Reardon, MD

  Methodist DeBakey Heart & Vascular Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 8, 2018
• Study Start: June 10, 2019
• Primary Completion: June 14, 2024
• Study Completion (Estimated): September 1, 2029
• Last Updated: May 4, 2026
• Results First Posted: April 27, 2025

Record last verified: 2026-04

Locations

CA (6); US (69)