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Aortic StenosisNCT03735667

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

A study testing ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System and Edwards SAPIEN 3 TAVR System in people with Aortic Stenosis, run by Boston Scientific Corporation at 75 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Aortic Stenosis
What is being tested?
ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System and Edwards SAPIEN 3 TAVR System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,948 participants
Where
75 sitesin 2 countries
Study dates
10 Jun 2019to Sep 2029
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 32Show fewer
  • 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.
  • EC16. Subject has any therapeutic invasive cardiac or vascular procedure within 30 days prior to the index procedure (except for balloon aortic valvuloplasty, pacemaker implantation, or implantable cardioverter defibrillator implantation, which are allowed).
  • EC17. Subject has untreated coronary artery disease, which in the opinion of the treating physician is clinically significant and requires revascularization.
  • EC18. Subject has severe left ventricular dysfunction with ejection fraction <20%.
  • EC19. Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
  • EC20. Subject has arterial access that is not acceptable for the study device (test or control) delivery systems as defined in the device (test or control) Directions For Use.
  • EC21. Subject has either of the following:
  • Severe vascular disease that would preclude safe access (e.g., aneurysm with thrombus that cannot be crossed safely; marked tortuosity; significant narrowing of the abdominal aorta; severe unfolding of the thoracic aorta; or thick, protruding, ulcerated atheroma in the aortic arch), OR
  • Severe/eccentric calcification of the aortic annulus that would prevent safe implantation of the TAVR prosthesis.
  • EC22. Subject has current problems with substance abuse (e.g., alcohol, etc.) that may interfere with the subject's participation in this study.
  • EC23. Subject is participating in another investigational drug or device study that has not reached its primary endpoint or subject intends to participate in another investigational device clinical trial within 12 months after index procedure.
  • EC24. Subject has untreated conduction system disorder (e.g., Type II second degree atrioventricular block) that in the opinion of the treating physician is clinically significant and requires a pacemaker implantation. Enrollment is permissible after permanent pacemaker implantation.
  • EC25. Subject has severe incapacitating dementia.
  • Additional exclusion criteria apply to subjects considered for enrollment in the CT Imaging Substudy as listed below.
  • AEC1. Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V)
  • AEC2. Subject has atrial fibrillation that cannot be rate controlled to ventricular response rate < 60 bpm.
  • AEC3. Subject is expected to undergo chronic anticoagulation therapy after the index procedure.
  • Note: Subjects treated with short-term anticoagulation post procedure can be included in the CT Imaging Substudy; in these subjects the 30-day imaging will be performed 30 days after discontinuation of anticoagulation.

Trial locations and contacts

75 sites in 2 countries.

75 sites in 2 countries

United States69 sites

  • Albany Medical Center

    Albany, New York, 12208

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Austin Heart

    Austin, Texas, 78705

  • Union Memorial Hospital

    Baltimore, Maryland, 21218

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • Kaleida Health

    Buffalo, New York, 14203

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Lindner Center for Research and Education at Christ Hospital

    Cincinnati, Ohio, 45219

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • OhioHealth Research and Innovation Institute

    Columbus, Ohio, 43214

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75226

  • Presbyterian Hospital of Dallas

    Dallas, Texas, 75231

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Englewood Health

    Englewood, New Jersey, 07631

  • Providence Regional Medical Center

    Everett, Washington, 98201

  • Endeavor Glenbrook Hospital

    Glenview, Illinois, 60026

  • Bellin Health

    Green Bay, Wisconsin, 54301

  • UPMC - Pinnacle

    Harrisburg, Pennsylvania, 17101

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • St. Vincent's Hospital

    Indianapolis, Indiana, 46290

  • University of Iowa

    Iowa City, Iowa, 52242

  • Scripps Clinic

    La Jolla, California, 92037

  • Baptist Health Medical Center

    Little Rock, Arkansas, 72205

  • Kaiser Permanente Los Angeles

    Los Angeles, California, 90027

  • Cedars-Sinai Heart Institute

    Los Angeles, California, 90048

  • Aurora Research Institute

    Milwaukee, Wisconsin, 53024

  • Medical College of Wisconsin - Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • St Thomas Ascension

    Nashville, Tennessee, 37205

  • Robert Wood Johnson Medical Center

    New Brunswick, New Jersey, 08901

  • 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

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

  • Orlando Regional Medical Center

    Orlando, Florida, 32806

  • Banner Good Samaritan

    Phoenix, Arizona, 85006

  • UPMC Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Baylor Regional Medical Center at Plano

    Plano, Texas, 75093

  • Providence Heart Institute

    Portland, Oregon, 97225

  • University of California, Davis Medical Center

    Sacramento, California, 95817

  • CentraCare Heart and Vascular Center

    Saint Cloud, Minnesota, 56303

  • St. Joseph's Hospital-St. Paul

    Saint Paul, Minnesota, 55102

  • Methodist Healthcare System of San Antonio dba Methodist Hospital

    San Antonio, Texas, 78229

  • Kaiser Permanente - San Francisco

    San Francisco, California, 94115

  • HonorHealth Scottsdale Healthcare

    Scottsdale, Arizona, 85260

  • St. John's Hospital (Prairie)

    Springfield, Illinois, 62769

  • Sacred Heart Medical Center - Riverbend

    Springfield, Oregon, 97477

  • Stanford University Medical Center

    Stanford, California, 94305

  • Montefiore-Jack D. Weiler Hospital

    The Bronx, New York, 10461

  • TMC HealthCare

    Tucson, Arizona, 85712

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Lexington Medical Center

    West Columbia, South Carolina, 29169

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

  • University of Massachusetts

    Worcester, Massachusetts, 01655

  • Lankenau

    Wynnewood, Pennsylvania, 19086

  • WellSpan York Hospital

    York, Pennsylvania, 17403

Other trials in United States

Canada6 sites

  • London Health Sciences

    London, Ontario, N6A 5A5

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 3E4

  • Royal Columbian Hospital

    New Westminster, British Columbia, V3L 3W5

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

    Québec, Quebec, G1V 4G5

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Providence Health - St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

Official title: ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve Through Implantation of ACURATE in Subjects InDicatEd for TAVR

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.

Read the detailed description

Subjects will be enrolled at up to 85 centers in the United States, Canada, Europe, and Australia. There will be up to 2,820 subjects in ACURATE IDE.

The ACURATE IDE study cohorts include the following.

  • Main Randomized Cohort: A prospective, multicenter, 1:1 randomized controlled trial (RCT; ACURATE versus a 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]). There will be up to 1,500 subjects in the RCT.
  • Roll-In Cohort: A non-randomized roll-in phase with the test device. Centers that do not have implantation experience with the ACURATE neo™ Aortic Bioprosthesis (transfemoral delivery; Boston Scientific Corporation, Marlborough, MA, USA) will perform at least 2 roll-in cases before commencing treatment in the randomized cohort. Centers with prior experience with ACURATE are not required to do roll-in cases. Data from roll-in subjects will be summarized separately from the randomized cohort and will not be included in the primary endpoint analysis.
  • 4D CT Imaging Substudy: Selected centers with the ability to perform high quality 4D computer tomography (CT) scans will include subjects in a 4D CT Imaging Substudy to assess the prevalence of reduced leaflet mobility and hypoattenuated leaflet thickening (HALT) and the relationship, if any, to clinical events. Subjects will be randomized to test (ACURATE) and control device.
  • ACURATE Prime™ XL Nested Registry: A non-randomized, nested registry cohort of subjects who will receive the ACURATE Prime™ Transfemoral Aortic Valve System XL (ACURATE Prime XL Nested Registry). Participating centers will be a subset of United States centers that have enrolled subjects in ACURATE IDE. Data from subjects in this nested registry will be summarized separately from the randomized and roll-in cohorts.
  • ACURATE Extended Durability Study: An additional 1:1 randomized study (ACURATE versus a 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]) including only subjects considered to be at low surgical risk. Subjects will receive ACURATE neo2 (S, M, or L valve sizes) or ACURATE Prime XL. Data from subjects in the Extended Durability Study will be summarized separately from other cohorts.
  • ACURATE Continued Access Study (CAS): An additional cohort of subjects receiving ACURATE neo2 (S, M, and L valve sizes) or ACURATE Prime XL. Data from subjects in the ACURATE CAS will be summarized separately from other cohorts and will be used to further assess performance and safety.

Follow-up

  • Subjects implanted with a test device will be assessed at baseline, peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, 1 year, and then annually for 5 years post-procedure.
  • Subjects implanted with a control device will be assessed at baseline, peri- and post-procedure, at discharge or 7 days post procedure (whichever comes first), 30 days, 6 months, and 1 year post procedure. Per protocol, no additional follow-up is required beyond this period, and standard of care practices will apply.
  • Some subjects may have completed additional annual follow-up visits based on requirements outlined in earlier versions of the protocol.
  • Subjects who are enrolled but not implanted with a test or control device at the time of the procedure will be followed for safety through 1 year.
Conditions
Aortic Stenosis
Being tested
ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System, ACURATE Prime™ Transfemoral TAVR System XL
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACURATE neo2™ Transfemoral TAVR SystemDevice

    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).

  • Medtronic CoreValve TAVR SystemDevice

    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).

  • Edwards SAPIEN 3 TAVR SystemDevice

    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)

  • ACURATE Prime™ Transfemoral TAVR System XLDevice

    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).

Study groups in NCT03735667
Study groupRoleWhat they receive
ACURATE Valve - Main RandomizedExperimentalPatients 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.
Receives: Device: ACURATE neo2™ Transfemoral TAVR System
ACURATE Valve - Single-arm Roll-inExperimentalPatients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
Receives: Device: ACURATE neo2™ Transfemoral TAVR System
Commercial Valve - Main RandomizedActive comparatorMedtronic 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.
Receives: Device: Medtronic CoreValve TAVR System; Device: Edwards SAPIEN 3 TAVR System
ACURATE Valve - Single-arm Prime XLExperimentalPatients 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
Receives: Device: ACURATE Prime™ Transfemoral TAVR System XL
ACURATE Valve - Extended Durability RandomizedExperimentalPatients 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.
Receives: Device: ACURATE neo2™ Transfemoral TAVR System; Device: ACURATE Prime™ Transfemoral TAVR System XL
Commercial Valve - Extended Durability RandomizedActive comparatorMedtronic 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.
Receives: Device: Medtronic CoreValve TAVR System; Device: Edwards SAPIEN 3 TAVR System
ACURATE Valve - Continued Access StudyExperimentalPatients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System (S, M, L) or ACURATE Prime™ transfemoral TAVR System XL.
Receives: Device: ACURATE neo2™ Transfemoral TAVR System; Device: ACURATE Prime™ Transfemoral TAVR System XL

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Participants will be followed for the duration of hospital stay through 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2018
  2. Study start10 Jun 2019
  3. Primary completion14 Jun 2024
  4. Study completionSep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,948 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03735667
Sponsor's protocol ID
S2408
Status last verified
Aug 2026
First submitted
6 Nov 2018
Last updated
16 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)

Publications

  • 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.

    PubMed 40406945

  • 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.

    PubMed 40412426

Questions about this trial

What is this clinical trial studying?

A study testing ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System and Edwards SAPIEN 3 TAVR System in people with Aortic Stenosis, run by Boston Scientific Corporation at 75 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Rate of All-cause Mortality, All Stroke, and Rehospitalization* at 1 Year in the Main Randomized Cohort. (time frame: Participants will be followed for the duration of hospital stay through 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03735667, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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