Study ID: ACURATE IDE
Researchers are evaluating the safety and effectiveness of the ACURATE neo2™ aortic valve system for transcatheter aortic valve replacement in symptomatic patients who have been diagnosed with aortic stenosis.
Eligible patients must be considered at intermediate or greater risk for standard surgical aortic valve replacement.
Study participants will undergo implantation with either the ACURATE neo2™ or another commercially available device. Patients will be assessed at baseline, peri- and post-procedure, at discharge, 30 days, six months, one year, and then annually for up to five years.
This multicenter study is evaluating the safety and effectiveness of the ACURATE neo2™ aortic valve system for transcatheter aortic valve replacement in symptomatic subjects with severe aortic stenosis and at intermediate or greater risk for standard SAVR. Eligible subjects must have documented severe native aortic stenosis defined as initial AVA ≤1.0 cm2 (or AVA index ≤ 0.6 cm2/m2) and a mean pressure gradient ≥40 mm Hg, or maximal aortic valve velocity ≥4.0 m/s or Doppler velocity index ≤0.25 as measured by echocardiography and/or invasive hemodynamics. Other inclusion criteria apply. Please contact the study coordinator for details.
Study cohorts include the following:
- Randomized cohort: Eligible patients are randomized 1:1 (ACURATE neo2 vs. any commercially available transcatheter aortic valve device), controlled trial. Randomization will be stratified by center.
- Roll-in cohort: A non-randomized roll-in phase of which each center will perform at least two roll-in cases before commencing enrollment in the randomized cohort. (Data from roll-in subjects will be summarized separately from the randomized cohort and will not be included in the primary endpoint analysis.)
The primary safety endpoint being measured is the composite of all-cause mortality, all stroke, life-threatening and major bleeding, stage 2 and 3 acute kidney injury, and major vascular complications at 30 days.
The primary effectiveness endpoint being measured is the composite of all-cause mortality and disabling stroke at one year.
- Must have been diagnosed with severe, symptomatic aortic stenosis
- Must be deemed at intermediate or greater risk for standard surgical aortic valve replacement
- Must agree to undergo implantation with study device or another device
- Must agree to all follow-up care