Symptomatic Severe Native Aortic StenosisNCT07278310
STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
A study testing TAVR Device and Siegel TAVR Device in people with Symptomatic Severe Native Aortic Stenosis and Aortic Stenosis, run by MiRus at 1 site in United States.
Trial summary
To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Severe Native Aortic Stenosis, Aortic Stenosis
- What is being tested?
- TAVR Device and Siegel TAVR Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,025 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2026to Apr 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are eligible for entry in this study if ALL the following conditions are met:
- Age ≥ 18 years
- 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
- New York Heart Association Functional Class ≥ 2
- 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)
- Eligible for transfemoral delivery of a TAVR
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- 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)
- Understands the study requirements and the treatment procedures and provides written informed consent
- Subject agrees to complete all required scheduled follow-up visits.
Who cannot join
- Subjects will be excluded for entry in this study if ANY of the following conditions are met:
- Anatomical
- Cardiac anatomy precluding safe placement of a transcatheter aortic valve.
- Iliofemoral vessel characteristics (vessel diameter <5.5mm for smaller THV systems [20-26mm valve sizes] or <6.0mm for larger THV systems [29mm or larger valve sizes]) that would preclude safe placement of commercially available transcatheter aortic valves (SAPIEN 3 or Evolut)
- Pre-existing prosthetic heart valve or ring except in the mitral position.
- Unicuspid aortic valve
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- Severe aortic regurgitation (>3+)
- Severe mitral or severe tricuspid regurgitation(>3+) requiring intervention.
- Moderate to severe mitral stenosis.
- Hypertrophic obstructive cardiomyopathy (HOCM)
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment.
- Significant aortic disease including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5.5 cm or greater or ascending aortic aneurysm defined as maximal luminal diameter 5 cm or greater.
- Clinical
- Evidence of an acute myocardial infarction ≤ 30 days before enrollment.
- Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
- Blood dyscrasias as defined: leukopenia (WBC < 3000 cell/mL, anemia (Hgb < 9 g/dL), thrombocytopenia (platelet count < 50,000 cells/mL), history of bleeding diathesis or coagulopathy.
- Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization
- Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support within the past 30 days.
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of enrollment
- Need for emergency surgery for any reason
- Ventricular dysfunction with left ventricular ejection fraction (LVEF) < 25% as measured by resting echocardiogram
- Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment
- Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy, or end stage renal disease requiring chronic dialysis
- GI bleeding within the past 3 months
- Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen
- History of cirrhosis or any active liver disease
- Significant abdominal or thoracic aortic disease (such as porcelain aorta, abdominal aortic aneurysm > 5.0 cm, severe calcification, aortic coarctation, etc.) that would preclude safe passage of the delivery system
- Severe pulmonary hypertension (e.g., PA systolic pressure ≥ 2/3 systemic pressure)
- A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, ticlopidine and clopidogrel, contrast media, nickel, cobalt ,chromium, titanium, molybdenum, rhenium, polyethylene materials.
- Ongoing sepsis, including active endocarditis
- BMI > 50 kg/m2
- Subject refuses a blood transfusion
- Life expectancy < 12 months due to associated non-cardiac co-morbid conditions
- Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent
- Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
- Currently participating in an investigational drug or another investigational device trial
- Subject is contraindicated for cardiac CT
- Subject belongs to a vulnerable population (Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Piedmont Heart Institute
Atlanta, Georgia, 30309
Principal Investigator, 404-605-5151, vinod.thourani@piedmont.org
Sub-Investigator, 404-605-5151, pradeep.yadav@piedmont.org
About this study
To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.
Read the 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.
- Being tested
- TAVR Device, Siegel TAVR Device
- Keywords
- Aortic Stenosis
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVR DeviceDevice
Commercially available TAVR Device
Siegel TAVR DeviceDevice
Siegel TAVR Device
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Investigational Device- Siegel TAVR Receives: Device: Siegel TAVR Device |
| Control Arm | Active comparator | Commercially available TAVR device- Sapien TAVR or Evolute TAVR Receives: Device: TAVR Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality, all stroke and cardiovascular rehospitalization
The primary endpoint is the composite of all-cause mortality, all stroke, and cardiovascular rehospitalization (valve-related or procedure-related per VARC-3) at 1 year.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
Apr 2026Apr 2028
- First posted12 Dec 2025
- Study startApr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Severe Native Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,025 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MiRus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278310
- Sponsor's protocol ID
- MR-002
- Status last verified
- Apr 2026
- First submitted
- 2 Dec 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No