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.
- 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. 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 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.