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

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Age: -1 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: aortic valve, heart valve, aortic valve replacement, transcatheter heart valve
Type: Device study
Target:
40 Participants
Investigator:
Description
This study will test the safety and effectiveness of the experimental ACURATE Valve System. It will be used for transcatheter aortic valve replacement (TAVR). TAVR is a minimally invasive method, using a vein in your leg to implant the device into your heart. This study is for patients with severe native aortic stenosis who are indicated for TAVR.

The ACURATE Valve System is an experimental device. This means that the valve is not currently approved for commercial use by the FDA.

The ACURATE Valve System consists of pig heart tissue processed by the manufacturer, attached to a delivery system. The valve tissue is sewn onto a metal frame made of nitinol (mostly nickel and titanium). The delivery system is a long tube with the valve attached at one end and a handle attached at the other end to control placement of the valve.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

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 ≥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.

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.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study team will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you $50.00 for your time and effort. You will receive this money via check in the mail for each follow up visit that you attend in person.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for 5 years after the day of your device implant procedure.
Recruitment period
From Aug. 22, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Kimberley Book
Research Topic
Conditions:
  • Aortic Stenosis