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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- 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.