IRB Study Number 26-193
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
Native Cohort: The purpose of this study is to evaluate the safety and the effectiveness of the DurAVR™ THV System in the treatment of patients with symptomatic severe native aortic stenosis. The DurAVR™ THV is a new product called an “investigational device”, meaning that it is not yet approved by regulatory authorities, such as the US Food and Drug Administration (FDA).
ViV Cohort: The purpose of the study is to find out if the DurAVR™ transcatheter heart valve (THV) System, the device that is being studied, is safe and effective in treating adults who have a degenerated surgically implanted bioprosthetic aortic valve. The DurAVR™ THV is a new product called an “investigational device”, meaning that it is not yet approved by regulatory authorities, such as the US Food and Drug Administration (FDA).
Inclusion Criteria
Native Valve Inclusion:
- The local Heart Team agrees that the subject has an appropriate indication for, and will benefit from, TAVR due to native calcific valve severe aortic stenosis.
- The subject is a candidate for TAVR using the DurAVR® THV System, and a SAPIEN series THV system or an Evolut series THV System.
- Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
ViV Inclusion:
- Severe degeneration of a surgically implanted aortic bioprosthetic valve.
- Subject requires aortic valve replacement and is high surgical risk and is indicated for TAVR Valve-in-Valve procedure as determined by the Heart Team.
- Subject agrees to complete all required scheduled follow-up visits.
Exclusion Criteria
Recent (within 90 days) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
Estimated life expectancy (after TAVR/ViV TAVR) < 12 months.
Current participation in an investigational drug study or another device study.
