Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07278310

STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)

Led by MiRus · Updated on 2026-04-09

1025

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.

CONDITIONS

Official Title

STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Symptomatic, severe native calcific aortic stenosis with 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 or higher
  • Requires aortic valve replacement and is indicated for TAVR as determined by an experienced Heart Team
  • Eligible for transfemoral delivery of TAVR
  • Native aortic annulus suitable for safe placement of Siegel 23mm, 26mm, or 29mm transcatheter heart valve based on preprocedural TTE and CT measurements
  • Understands study requirements and treatment procedures and provides written informed consent
  • Agrees to complete all scheduled follow-up visits
Not Eligible

You will not qualify if you...

  • Cardiac anatomy preventing safe placement of a transcatheter aortic valve
  • Iliofemoral vessel diameter less than 5.5mm for smaller valves (20-26mm) or less than 6.0mm for larger valves (29mm or larger)
  • Presence of a prosthetic heart valve or ring except in the mitral position
  • Unicuspid aortic valve
  • Severe aortic regurgitation greater than 3+
  • Severe mitral or tricuspid regurgitation greater than 3+ requiring intervention
  • Moderate to severe mitral stenosis
  • Hypertrophic obstructive cardiomyopathy
  • Intracardiac mass, thrombus, or vegetation requiring treatment
  • Significant aortic disease including abdominal or thoracic aneurysm ≥ 5.5 cm or ascending aortic aneurysm ≥ 5 cm
  • Acute myocardial infarction within 30 days prior to enrollment
  • Percutaneous coronary or peripheral intervention within 30 days prior to the procedure
  • Blood disorders such as leukopenia, anemia, thrombocytopenia, bleeding diathesis, or coagulopathy
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Cardiogenic shock or need for inotropic, mechanical ventilation, or heart support within 30 days
  • Emergency surgery requirement
  • Left ventricular ejection fraction below 25%
  • Stroke or transient ischemic attack within 6 months
  • Symptomatic carotid or vertebral artery disease or recent carotid stenosis treatment
  • Severe renal insufficiency or dialysis dependency
  • Gastrointestinal bleeding within past 3 months
  • Severe lung disease or home oxygen use
  • History of liver disease or cirrhosis
  • Severe abdominal or thoracic aortic conditions impeding device passage
  • Severe pulmonary hypertension
  • Known allergies or contraindications to study medications or device materials
  • Active sepsis or endocarditis
  • Body mass index over 50 kg/m2
  • Refusal of blood transfusion
  • Life expectancy under 12 months due to non-cardiac conditions
  • Medical, social, or psychological conditions preventing consent or compliance
  • Severe dementia preventing informed consent or independent lifestyle
  • Participation in another investigational drug or device trial
  • Contraindication for cardiac CT
  • Vulnerable populations such as mentally disabled, institutionalized, children, homeless, refugees, or others unable to give informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Piedmont Heart Institute

Atlanta, Georgia, United States, 30309

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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