ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
- Conditions
- Aortic Stenosis
- Registration Number
- NCT03735667
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 1948
Inclusion Criteria:<br><br> - IC1. Subject has documented severe symptomatic native aortic stenosis defined as<br> follows: aortic valve area (AVA) =1.0 cm2 (or AVA index =0.6 cm2/m2) AND a mean<br> pressure gradient =40 mmHg, OR maximal aortic valve velocity =4.0 m/s, OR Doppler<br> velocity index =0.25 as measured by echocardiography and/or invasive hemodynamics.<br><br>Note: In cases of low flow, low gradient aortic stenosis with left ventricular<br>dysfunction (ejection fraction <50%), dobutamine can be used to assess the grade of<br>aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min recommended); the subject may<br>be enrolled if echocardiographic criteria are met with this augmentation.<br><br> - IC2. Subject has a documented aortic annulus size of =20.5 mm and =29 mm based on<br> the center's assessment of pre-procedure diagnostic imaging (and confirmed by the<br> Case Review Committee [CRC]) and, for the Main Randomized Cohort and the Extended<br> Durability Study, is deemed treatable with an available size of both test and<br> control device.<br><br> - IC3. For subjects with symptomatic aortic valve stenosis per IC1 definition above,<br> functional status is NYHA Functional Class = II.<br><br> - IC4. Heart team (which must include an experienced cardiac interventionalist and an<br> experienced cardiac surgeon) agrees that the subject is indicated for TAVR, is<br> likely to benefit from valve replacement, and TAVR is appropriate.<br><br> - IC5. Subject (or legal representative) understands the study requirements and the<br> treatment procedures, and provides written informed consent.<br><br> - IC6. Subject, family member, and/or legal representative agree(s) and subject is<br> capable of returning to the study hospital for all required scheduled follow up<br> visits.<br><br> - IC7. Subject is expected to be able to take the protocol-required adjunctive<br> pharmacologic therapy.<br><br>Exclusion Criteria:<br><br> - EC1. Subject has a unicuspid or bicuspid aortic valve.<br><br> - EC2. Subject has had an acute myocardial infarction within 30 days prior to the<br> index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation =<br> twice normal in the presence of CK-MB elevation and/or troponin elevation).<br><br> - EC3. Subject has had a cerebrovascular accident or transient ischemic attack<br> clinically confirmed by a neurologist or neuroimaging within the past 6 months prior<br> to study enrollment.<br><br> - EC4. Subject is on renal replacement therapy or has eGFR <20.<br><br> - EC5. Subject has a pre-existing prosthetic aortic or mitral valve.<br><br> - EC6. Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.<br><br> - EC7. Subject has moderate or severe mitral stenosis (mitral valve area =1.5 cm2 and<br> diastolic pressure half-time =150 ms, Stage C or D76).<br><br> - EC8. Subject has a need for emergency surgery for any reason.<br><br> - EC9. Subject has a history of endocarditis within 6 months of index procedure or<br> evidence of an active systemic infection or sepsis.<br><br> - EC10. Subject has echocardiographic evidence of new intra-cardiac vegetation or<br> intraventricular or paravalvular thrombus requiring intervention.<br><br> - EC11. Subject has platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white<br> blood cell count <1,000 cells/mm3.<br><br> - EC12. Subject has had a gastrointestinal bleed requiring hospitalization or<br> transfusion within the past 3 months, or has other clinically significant bleeding<br> diathesis or coagulopathy that would preclude treatment with required antiplatelet<br> regimen, or will refuse transfusions.<br><br> - EC13. Subject has known hypersensitivity to contrast agents that cannot be<br> adequately pre-medicated, or has known hypersensitivity to the protocol required<br> medications (aspirin, all P2Y12 inhibitors, heparin), or to the individual<br> components of the test or control valve (nickel, titanium, stainless steel,<br> platinum, iridium or polyethylene terephthalate [PET]).<br><br> - EC14. Subject has a life expectancy of less than 12 months due to non-cardiac,<br> comorbid conditions based on the assessment of the investigator at the time of<br> enrollment.<br><br> - EC15. Subject has hypertrophic cardiomyopathy.<br><br> - EC16. Subject has any therapeutic invasive cardiac or vascular procedure within 30<br> days prior to the index procedure (except for balloon aortic valvuloplasty,<br> pacemaker implantation, or implantable cardioverter defibrillator implantation,<br> which are allowed).<br><br> - EC17. Subject has untreated coronary artery disease, which in the opinion of the<br> treating physician is clinically significant and requires revascularization.<br><br> - EC18. Subject has severe left ventricular dysfunction with ejection fraction <20%.<br><br> - EC19. Subject is in cardiogenic shock or has hemodynamic instability requiring<br> inotropic support or mechanical support devices.<br><br> - EC20. Subject has arterial access that is not acceptable for the study device (test<br> or control) delivery systems as defined in the device (test or control) Directions<br> For Use.<br><br> - EC21. Subject has either of the following:<br><br> - Severe vascular disease that would preclude safe access (e.g., aneurysm with<br> thrombus that cannot be crossed safely; marked tortuosity; significant<br> narrowing of the abdominal aorta; severe unfolding of the thoracic aorta; or<br> thick, protruding, ulcerated atheroma in the aortic arch), OR<br><br> - Severe/eccentric calcification of the aortic annulus that would prevent safe<br> implantation of the TAVR prosthesis.<br><br> - EC22. Subject has current problems with substance abuse (e.g., alcohol, etc.) that<br> may interfere with the subject's participation in this study.<br><br> - EC23. Subject is participating in another investigational drug or device study that<br> has not reached its primary endpoint or subject intends to participate in another<br> investigational device clinical trial within 12 months after index procedure.<br><br> - EC24. Subject has untreated conduction system disorder (e.g., Type II second degree<br> atrioventricular block) that in the opinion of the treating physician is clinically<br> significant and requires a pacemaker implantation. Enrollment is permissible after<br> permanent pacemaker implantation.<br><br> - EC25. Subject has severe incapacitating dementia.<br><br>Additional exclusion criteria apply to subjects considered for enrollment in the CT<br>Imaging Substudy as listed below.<br><br> - AEC1. Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V)<br><br> - AEC2. Subject has atrial fibrillation that cannot be rate controlled to ventricular<br> response rate < 60 bpm.<br><br> - AEC3. Subject is expected to undergo chronic anticoagulation therapy after the index<br> procedure.<br><br>Note: Subjects treated with short-term anticoagulation post procedure can be included in<br>the CT Imaging Substudy; in these subjects the 30-day imaging will be performed 30 days<br>after discontinuation of anticoagulation.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite rate of all-cause mortality, all stroke, and rehospitalization at 1 year in the Main Randomized Cohort.
- Secondary Outcome Measures
Name Time Method