IRB Study Number 19-659
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
Evaluate safety and effectiveness of the ACURATE TransfemoralAortic Valve System for transcatheter aortic valve replacement (TAVR)in subjects with severe native aortic stenosis who are indicated forTAVR
Inclusion Criteria
- Documented severe symptomatic native aortic stenosis
- Study-defined heart team agrees that the subject is indicated for TAVR, is likely to benefit from valve replacement, and TAVR is appropriate
- Subject has an appropriate aortic annulus size based on the center’s assessment of pre-procedure diagnostic imaging, and confirmed by the Case Review Committee
- Additional inclusion criteria will be evaluated by study staff
Exclusion Criteria
- Subject has a unicuspid or bicuspid aortic valve
- Subject has had an acute myocardial infarction within 30 days prior to the index procedure
- Subject has had a cerebrovascular accident or transient ischemic attack clinically confirmed by a neurologist or neuro imaging within the past 6 months prior to study enrollment
- Additional exclusion criteria will be evaluated by study staff
