Trial Search Results
ACURATE IDE: Safety and Efficacy Study of Acurate Valve for Transcatheter Aortic Valve Replacement
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.
Stanford is currently accepting patients for this trial.
Boston Scientific Corporation
- Device: ACURATE neo2™ Transfemoral TAVR System
- Device: Medtronic CoreValve TAVR System
- Device: Edwards SAPIEN 3 TAVR System
- 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 ≥21 mm and ≤27 mm based on the
center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case
Review Committee [CRC]) and, for the randomized cohort, 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 at intermediate risk or above
for surgical valve replacement and TAVR is appropriate. Heart team should consider the
STS score as well as other factors including frailty, prior surgical history,
malignancy or radiation therapy, deformity, and aortic calcification. Subjects
considered to be at intermediate risk or above have a predicted risk of surgical
mortality ≥ 3% based on the STS risk score and other clinical comorbidities unmeasured
by the STS risk calculator.
Note 1: Risk of operative mortality must be assessed via an in-person evaluation by a
center cardiac surgeon and must be confirmed by the CRC (which must include an experienced
Note 2: At the time this protocol was written, subjects at extreme and high surgical risk
were approved for TAVR with commercially available devices in the United States and Canada.
Subjects at intermediate surgical risk were approved for TAVR with select commercially
available devices in the United States and Canada. Subjects at low surgical risk were
subsequently approved for TAVR with commercially available devices in the United States.
- IC5. Heart team (which must include an experienced cardiac interventionalist and an
experienced cardiac surgeon) agrees that the subject is likely to benefit from valve
- IC6. Subject (or legal representative) understands the study requirements and the
treatment procedures, and provides written informed consent.
- IC7. 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
- IC8. Subject is expected to be able to take the protocol-required adjunctive
- 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
- 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
- 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
- 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
- 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
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.
Ages Eligible for Study
N/A - N/A
Genders Eligible for Study