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.
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
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
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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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 Receives: 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. Receives: 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. Receives: 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. 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.
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.
- First posted8 Nov 2018
- Study start10 Jun 2019
- Primary completion14 Jun 2024
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raj R. Makkar, MD, Principal investigator, Cedars-Sinai Heart InstituteMichael J. Reardon, MD, Principal investigator, Methodist DeBakey Heart & Vascular Center
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 40406945Makkar 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