STAR Trial for Symptomatic Severe Aortic Stenosis

This study, called the STAR Trial, is looking at a new device called the Siegel TAVR Device for people with severe aortic stenosis (a condition where the heart's aortic valve is narrowed). Researchers want to see if the Siegel TAVR Device is safe and works well compared to commercially available TAVR devices. You might be able to join if you are 18 or older, have symptomatic severe native calcific aortic stenosis, and meet specific measurements for your aortic valve. The study aims to enroll about 1025 participants. The main goals are to see how many people experience death, stroke, or need to be rehospitalized for heart-related issues after one year. The current recruitment status is unclear.

Study design
This is an interventional study comparing the Siegel TAVR Device with other available TAVR devices, involving approximately 1025 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least one year to monitor for all-cause mortality, all stroke, and cardiovascular rehospitalization.

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NCT07278310

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

Recruiting
NAAges 18+InterventionalTreatment
MiRus
~1,025 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:TAVR DeviceSiegel TAVR Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
All-cause mortality, all stroke and cardiovascular rehospitalization
Measured over 1 Year
Symptomatic Severe Native Aortic Stenosis
Aortic Stenosis
1 sites across 1 states
Georgia1

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  • All-cause mortality, all stroke and cardiovascular rehospitalization1 Year

    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.