NCT07278310 STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
| NCT ID | NCT07278310 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MiRus |
| Condition | Symptomatic Severe Native Aortic Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,025 participants |
| Start Date | 2026-04 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,025 participants in total. It began in 2026-04 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.
Eligibility Criteria
Inclusion Criteria: Subjects are eligible for entry in this study if ALL the following conditions are met: 1. Age ≥ 18 years 2. Symptomatic, severe native calcific aortic stenosis in subjects at low, intermediate or high surgical risk AVA ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 or Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg or dimensionless Index \<0.25 3. New York Heart Association Functional Class ≥ 2 4. Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team (composed of an experienced interventional cardiologist and an experienced cardiac surgeon) 5. Eligible for transfemoral delivery of a TAVR 6. Native aortic annulus suitable for safe placement of Siegel 23mm, 26mm or 29 mm transcatheter heart valve. Preprocedural measurements by TTE and CT of aortic annulus area (23mm: 330- 440 mm2 , 26mm: 430-550 mm2, 29mm: 540-690 mm2) 7. Understands the study requirements and the treatment procedures and provides written informed consent 8. Subject agrees
Frequently Asked Questions
Who can join the NCT07278310 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Symptomatic Severe Native Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07278310 currently recruiting?
Yes, NCT07278310 is actively recruiting participants. Visit ClinicalTrials.gov or contact MiRus to inquire about joining.
Where is the NCT07278310 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT07278310 clinical trial?
NCT07278310 is sponsored by MiRus. The trial plans to enroll 1,025 participants.