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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
MiRus
Study ID
NCT07278310
Status
Recruiting
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Conditions

  • Aortic Stenosis
  • Symptomatic Severe Native Aortic Stenosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TAVR Device — DEVICE
    Commercially available TAVR Device
  • Siegel TAVR Device — DEVICE
    Siegel TAVR Device

Study Details

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

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
1,025 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Investigational Device- Siegel TAVR
  • Active Comparator: Control Arm
    Commercially available TAVR device- Sapien TAVR or Evolute TAVR

Primary Outcome Measure

All-cause mortality, all stroke and cardiovascular rehospitalization [ Time Frame: 1 Year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Piedmont Heart InstituteAtlantaGeorgia30309
Principal Investigator
[email protected]
404-605-5151
Sub-Investigator
[email protected]
404-605-5151
Vinod Thourani, MD (PRINCIPAL_INVESTIGATOR)
Pradeep Yadav (SUB_INVESTIGATOR)

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By research site
Piedmont Heart Institute· Atlanta, GA

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