Summary

at Sacramento, California and other locations
study started
estimated completion

Description

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.

Official Title

ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve Through Implantation of ACURATE in Subjects InDicatEd for TAVR

Details

Subjects will be enrolled at up to 50 centers in the United States and Canada. There will be up to 600 subjects in ACURATE IDE.

The ACURATE IDE study cohorts include the following.

  • 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 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; Symetis SA, Ecublens, Switzerland) will perform at least 2 roll-in cases before commencing enrollment 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.

All subjects implanted will be followed at baseline, peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and then annually for up to 5 years post-procedure. Enrolled subjects who do not have a study device implanted will be assessed through 1-year post-procedure for safety/adverse events.

Keywords

Aortic Stenosis Aortic Valve Stenosis ACURATE neo2™ Transfemoral TAVR System Medtronic CoreValve TAVR System Edwards SAPIEN 3 TAVR System

Eligibility

You can join if…

  • 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 cardiac surgeon).

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.

  • 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 replacement.
  • 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 visits.
  • IC8. Subject is expected to be able to take the protocol-required adjunctive pharmacologic therapy.

You CAN'T join if...

  • 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.

Locations

  • University of California, Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Kaiser Permanente - San Francisco accepting new patients
    San Francisco California 94115 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boston Scientific Corporation
Links
Sign up for this study
ID
NCT03735667
Study Type
Interventional
Last Updated