IRB Study Number 23-171
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
Evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis
Inclusion Criteria
- Symptomatic, severe native aortic stenosis in subjects 65 years or older
- Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team
- Anatomy appropriate to accommodate safe placement of DurAVR™ THV
- Other inclusion criteria will be assessed by study team
Exclusion Criteria
- Pre-existing prosthetic heart valve in any position
- Anatomy precluding safe placement of DurAVR™ THV
- Unicuspid or bicuspid aortic valve
- Other exclusion criteria will be assessed by study team
