New heart valve device shows promise, but trial halted early

NCT ID NCT03735667

Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This study tested a new device called the ACURATE neo2, which replaces a narrowed heart valve without open-heart surgery. About 1,900 people with severe aortic stenosis received either the new device or a standard one. The goal was to see if the new device is safe and works as well. However, the company stopped the trial and will not seek approval, so the device is not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ACURATE neo2 Transfemoral TAVR System (a replacement heart valve implanted via a catheter)
What this could lead to: If successful, this device could offer a new option for replacing narrowed heart valves without open-heart surgery, potentially improving survival and quality of life.
What could go wrong: The trial was discontinued by the sponsor, so results may not lead to approval. As with any heart procedure, risks include stroke, bleeding, or valve complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1,948 people

The number who actually took part.

Started

Jun 2019

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. 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.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic stenosis

Contacts and locations

Locations

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States
Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States
Albany Medical Center

Albany, New York, 12208, United States
Aurora Research Institute

Milwaukee, Wisconsin, 53024, United States
Austin Heart

Austin, Texas, 78705, United States
Banner Good Samaritan

Phoenix, Arizona, 85006, United States
Baptist Health Medical Center

Little Rock, Arkansas, 72205, United States
Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States
Baylor Regional Medical Center at Plano

Plano, Texas, 75093, United States
Bellin Health

Green Bay, Wisconsin, 54301, United States
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
Carolinas Medical Center

Charlotte, North Carolina, 28203, United States
Cedars-Sinai Heart Institute

Los Angeles, California, 90048, United States
CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, 56303, United States
Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2X 3E4, Canada
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Columbia University Medical Center/NYPH

New York, New York, 10032, United States
Cornell Presbyterian - New York

New York, New York, 10065, United States
Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States
Endeavor Glenbrook Hospital

Glenview, Illinois, 60026, United States
Englewood Health

Englewood, New Jersey, 07631, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
HonorHealth Scottsdale Healthcare

Scottsdale, Arizona, 85260, United States
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

Québec, Quebec, G1V 4G5, Canada
Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States
Kaiser Permanente - San Francisco

San Francisco, California, 94115, United States
Kaiser Permanente Los Angeles

Los Angeles, California, 90027, United States
Kaleida Health

Buffalo, New York, 14203, United States
Lankenau

Wynnewood, Pennsylvania, 19086, United States
Lexington Medical Center

West Columbia, South Carolina, 29169, United States
Lindner Center for Research and Education at Christ Hospital

Cincinnati, Ohio, 45219, United States
London Health Sciences

London, Ontario, N6A 5A5, Canada
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Medical College of Wisconsin - Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Methodist Healthcare System of San Antonio dba Methodist Hospital

San Antonio, Texas, 78229, United States
Montefiore-Jack D. Weiler Hospital

The Bronx, New York, 10461, United States
Morton Plant Hospital

Clearwater, Florida, 33756, United States
Mount Sinai Medical Center

New York, New York, 10029, United States
OhioHealth Research and Innovation Institute

Columbus, Ohio, 43214, United States
Orlando Regional Medical Center

Orlando, Florida, 32806, United States
Piedmont Hospital

Atlanta, Georgia, 30309, United States
Presbyterian Hospital of Dallas

Dallas, Texas, 75231, United States
Providence Health - St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada
Providence Heart Institute

Portland, Oregon, 97225, United States
Providence Regional Medical Center

Everett, Washington, 98201, United States
Robert Wood Johnson Medical Center

New Brunswick, New Jersey, 08901, United States
Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W5, Canada
Sacred Heart Medical Center - Riverbend

Springfield, Oregon, 97477, United States
Scripps Clinic

La Jolla, California, 92037, United States
Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States
St Thomas Ascension

Nashville, Tennessee, 37205, United States
St. John's Hospital (Prairie)

Springfield, Illinois, 62769, United States
St. Joseph's Hospital-St. Paul

Saint Paul, Minnesota, 55102, United States
St. Vincent's Hospital

Indianapolis, Indiana, 46290, United States
Stanford University Medical Center

Stanford, California, 94305, United States
Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada
TMC HealthCare

Tucson, Arizona, 85712, United States
The Methodist Hospital Research Institute

Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States
The University of Vermont Medical Center

Burlington, Vermont, 05401, United States
UPMC - Pinnacle

Harrisburg, Pennsylvania, 17101, United States
UPMC Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States
Union Memorial Hospital

Baltimore, Maryland, 21218, United States
University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States
University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States
University of California, Davis Medical Center

Sacramento, California, 95817, United States
University of Iowa

Iowa City, Iowa, 52242, United States
University of Massachusetts

Worcester, Massachusetts, 01655, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of North Carolina

Chapel Hill, North Carolina, 27514, United States
University of Virginia Health System

Charlottesville, Virginia, 22908, United States
Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States
WellSpan York Hospital

York, Pennsylvania, 17403, United States

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