Siegel™ Transcatheter Aortic Valve Replacement System (TAVR) Early Feasibility Study

Running, not enrolling · Not applicable

Conditions studied: Aortic Stenosis Symptomatic

In brief

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.

Key facts

Study ID

NCT06680427

Run by

MiRus

People needed

30

Starts

2025-03-26

Expected to finish

2025-12-01

Last updated by the study team

2025-12-03

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects are eligible for entry in this study if all the following conditions are met:
• Symptomatic, severe native aortic stenosis in subjects 50 years or older Aortic Valve Area (AVA) ≤ 1.0 cm2 or Aortic Valve Area (AVA) index ≤ 0.6 cm2/m2 and 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 the Siegel TAVR
• Native aortic annulus suitable for safe placement of Siegel 23mm or 26mm transcatheter heart valve (preprocedural measurements by Transthoracic Echocardiogram (TTE) and Computed Tomography (CT) of area derived aortic annulus diameter)
• Understands the study requirements and the treatment procedures and provides written informed consent
• Subject agrees to complete all required scheduled follow-up visits.

You may not qualify if…

• Subjects will be excluded for entry in this study if any of the following conditions are met:
• Anatomical
• Anatomy precluding safe placement of Siegel TAVR
• Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
• Pre-existing prosthetic heart valve in any position (note, mitral ring is not an exclusion).
• Unicuspid or bicuspid aortic valve
• Severe aortic regurgitation (>3+)
• Severe mitral or severe tricuspid regurgitation(>3+) requiring intervention.
• Moderate to severe mitral stenosis.
• Hypertrophic obstructive cardiomyopathy
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment.
• Severe basal septal hypertrophy with outflow gradient 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) < 30% 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 with Forced Expiratory Volume in 1 second (FEV1) < 50% predicted or currently on home oxygen

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Stanford — Palo Alto, California, United States
• NCH Healthcare System — Naples, Florida, United States
• Piedmont Healthcare — Atlanta, Georgia, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Atlantic Health System — Morristown, New Jersey, United States
• Columbia University Medical Center/ NYPH — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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