Active, not recruitingNCT06680427
Siegel™ Transcatheter Aortic Valve Replacement System (TAVR) Early Feasibility Study
AI Description
The Siegel™ Transcatheter Aortic Valve (TAVR) early feasibility study objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement.
- Who can join
- adult, older adult
- Participants
- 30
- Expected completion
- 2025-12
- Funded by
- industry
Conditions studied
Aortic Stenosis Symptomatic
What is being tested
- DEVICE: Siegel Transcatheter Aortic Valve (TAVR)
What it measures
- All-cause mortality or disabling stroke, Mortality will be reported as rate of death/mortality at 30 days. Disabling stroke will be reported according to Valve Academic Research Consortium (VARC-3) Guidelines, 30 Days
- Technical success of implantation of the Siegel TAVR, Technical success will be reported as freedom from mortality, successful device implant, and freedom from surgery or intervention related to the device., Immediate post procedure
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Registry entry updated 2025-12-03
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.