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

MiRus

Status

Not yet enrolling

Conditions

Symptomatic Severe Native Aortic Stenosis

Aortic Stenosis

Treatments

Device: Siegel TAVR Device

Device: TAVR Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT07278310

MR-002

Details and patient eligibility

About

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

Full 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.

Enrollment

1,025 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
Native aortic annulus suitable for safe placement of Siegel 23mm, transcatheter heart valve. Preprocedural measurements by TTE and CT of aortic annulus area (330- 440 mm2 )
Understands the study requirements and the treatment procedures and provides written informed consent
Subject agrees to complete all required scheduled follow-up visits.

Exclusion criteria

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 anatomy (vessel diameter < 5.5mm) precluding 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
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).