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New treatment option for Symptomatic Severe Native Aortic Stenosis
Official title STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
ClinicalTrials.gov ID: NCT07278310
What this study is testing
- What it's testing
- To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people are eligible for entry in this study if ALL the following conditions are met:
- Age ≥ 18 years
- Symptomatic, severe native calcific aortic stenosis in people at low, intermediate or high surgical risk AVA ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 or...
- 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 treatment cardiologist and an...
You likely can't join if
- people 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...
- Pre-existing prosthetic heart valve or ring except in the mitral position.
- Unicuspid aortic valve
- Severe aortic regurgitation (\>3+)
See the full eligibility criteria
Who can join
- people are eligible for entry in this study if ALL the following conditions are met:
- Age ≥ 18 years
- Symptomatic, severe native calcific aortic stenosis in people 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...
- 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 treatment cardiologist and an experienced cardiac surgeon)
- Eligible for transfemoral delivery of a TAVR
- 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...
- Understands the study requirements and the treatment procedures and provides written informed consent
- Subject agrees to complete all required scheduled follow-up visits.
What rules you out
- people 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...
- 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 treatment 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.