STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMiRus
About this trial
To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
TAVR Device
DeviceCommercially available TAVR Device
Siegel TAVR Device
DeviceSiegel TAVR Device
Treatment groups
1,025 Participants
are divided into 2 treatment groupsGroup A: Treatment ArmExperimental treatment 1 intervention
Group B: Control ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1 Year Source ClinicalTrials.gov