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

NCT ID: NCT03735667

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1948 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-10
• Study Completion Date: 2029-09-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACURATE Valve - Main Randomized

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.

Group Type: EXPERIMENTAL

ACURATE neo2™ Transfemoral TAVR System

Intervention Type: 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 - Single-arm Roll-in

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

Group Type: EXPERIMENTAL

ACURATE neo2™ Transfemoral TAVR System

Intervention Type: 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).

Commercial Valve - Main Randomized

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.

Group Type: ACTIVE_COMPARATOR

Medtronic CoreValve TAVR System

Intervention Type: 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).

Edwards SAPIEN 3 TAVR System

Intervention Type: 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)

ACURATE Valve - Single-arm Prime XL

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

Group Type: EXPERIMENTAL

ACURATE Prime™ Transfemoral TAVR System XL

Intervention Type: 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 - Extended Durability Randomized

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.

Group Type: EXPERIMENTAL

ACURATE neo2™ Transfemoral TAVR System

Intervention Type: 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 Prime™ Transfemoral TAVR System XL

Intervention Type: 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).

Commercial Valve - Extended Durability Randomized

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.

Group Type: ACTIVE_COMPARATOR

Medtronic CoreValve TAVR System

Intervention Type: 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).

Edwards SAPIEN 3 TAVR System

Intervention Type: 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)

ACURATE Valve - Continued Access Study

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

Group Type: EXPERIMENTAL

ACURATE neo2™ Transfemoral TAVR System

Intervention Type: 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 Prime™ Transfemoral TAVR System XL

Intervention Type: 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).

Interventions

ACURATE neo2™ Transfemoral TAVR System

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).

Intervention Type: DEVICE

Medtronic CoreValve TAVR System

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).

Intervention Type: DEVICE

Edwards SAPIEN 3 TAVR System

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)

Intervention Type: DEVICE

ACURATE Prime™ Transfemoral TAVR System XL

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raj R. Makkar, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Heart Institute

Michael J. Reardon, MD

Role: PRINCIPAL_INVESTIGATOR

Methodist DeBakey Heart & Vascular Center

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Banner Good Samaritan

Phoenix, Arizona, United States

HonorHealth Scottsdale Healthcare

Scottsdale, Arizona, United States

TMC HealthCare

Tucson, Arizona, United States

Baptist Health Medical Center

Little Rock, Arkansas, United States

Scripps Clinic

La Jolla, California, United States

Kaiser Permanente Los Angeles

Los Angeles, California, United States

Cedars-Sinai Heart Institute

Los Angeles, California, United States

University of California, Davis Medical Center

Sacramento, California, United States

Kaiser Permanente - San Francisco

San Francisco, California, United States

Stanford University Medical Center

Stanford, California, United States

MedStar Washington Hospital Center

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

Morton Plant Hospital

Clearwater, Florida, United States

Orlando Regional Medical Center

Orlando, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

NorthShore University Health Study Coordinator

Evanston, Illinois, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

St. John's Hospital (Prairie)

Springfield, Illinois, United States

St. Vincent's Hospital

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Union Memorial Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Massachusetts

Worcester, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, United States

St. Joseph's Hospital-St. Paul

Saint Paul, Minnesota, United States

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Englewood Health

Englewood, New Jersey, United States

Robert Wood Johnson Medical Center

New Brunswick, New Jersey, United States

Albany Medical Center

Albany, New York, United States

Kaleida Health

Buffalo, New York, United States

Mount Sinai Medical Center

New York, New York, United States

Columbia University Medical Center/NYPH

New York, New York, United States

Cornell Presbyterian - New York

New York, New York, United States

Montefiore-Jack D. Weiler Hospital

The Bronx, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Lindner Center for Research and Education at Christ Hospital

Cincinnati, Ohio, United States

University Hospitals of Cleveland

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

OhioHealth Research and Innovation Institute

Columbus, Ohio, United States

Integris Baptist Medical Center

Oklahoma City, Oklahoma, United States

Providence Heart Institute

Portland, Oregon, United States

Sacred Heart Medical Center - Riverbend

Springfield, Oregon, United States

UPMC - Pinnacle

Harrisburg, Pennsylvania, United States

UPMC Pittsburgh

Pittsburgh, Pennsylvania, United States

Lankenau

Wynnewood, Pennsylvania, United States

WellSpan York Hospital

York, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Lexington Medical Center

West Columbia, South Carolina, United States

St Thomas Ascension

Nashville, Tennessee, United States

Austin Heart

Austin, Texas, United States

Baylor Heart and Vascular Hospital

Dallas, Texas, United States

Presbyterian Hospital of Dallas

Dallas, Texas, United States

The Methodist Hospital Research Institute

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Baylor Regional Medical Center at Plano

Plano, Texas, United States

Methodist Healthcare System of San Antonio dba Methodist Hospital

San Antonio, Texas, United States

The University of Vermont Medical Center

Burlington, Vermont, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Providence Regional Medical Center

Everett, Washington, United States

Bellin Health

Green Bay, Wisconsin, United States

Aurora Research Institute

Milwaukee, Wisconsin, United States

Medical College of Wisconsin - Froedtert Hospital

Milwaukee, Wisconsin, United States

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Providence Health - St. Paul's Hospital

Vancouver, British Columbia, Canada

London Health Sciences

London, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

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

Québec, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: BACKGROUND

PMID: 40406945 (View on PubMed)

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.

Reference Type: RESULT

PMID: 40412426 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

S2408

Identifier Type: -

Identifier Source: org_study_id