Trials / Recruiting
RecruitingNCT07278310
STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,025 (estimated)
- Sponsor
- MiRus · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.
Detailed description
The primary objective is to assess the acute and long-term safety and efficacy of the Siegel THV device in adult subjects with symptomatic, severe native calcific aortic stenosis eligible for the transcatheter aortic valve replacement.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TAVR Device | Commercially available TAVR Device |
| DEVICE | Siegel TAVR Device | Siegel TAVR Device |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2028-04-01
- Completion
- 2028-04-01
- First posted
- 2025-12-12
- Last updated
- 2026-04-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07278310. Inclusion in this directory is not an endorsement.