HALT Biomarker Study for Aortic Stenosis
This study, called the HALT Biomarker Study, is looking for better ways to detect Hypo-Attenuated Leaflet Thickening (HALT). HALT is a condition where the leaflets of a heart valve thicken, which can happen after a procedure called TAVR (transcatheter aortic valve replacement). Researchers want to find specific proteins in your blood that can help doctors diagnose HALT earlier and predict who might develop it. They also want to see how these proteins change after HALT is treated with blood thinners. You may be able to join if you are over 65, have severe aortic stenosis or a failing bioprosthetic valve, and are having a TAVR procedure with a Medtronic Evolut valve. The study aims to enroll about 300 patients.
- Study design
- This is an interventional study. It plans to enroll up to 300 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure outcomes at 6 months to see changes in circulating proteins and the rate of future HALT characteristics.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The HALT Biomarker Study
At a glance
Conditions
Where it's being run
3 sites across 3 statesWho to contact
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What this trial measures
- Derivation of the panel of circulating proteins indicative of HALT6 months
1\. Establish the incidence of similar proteomic profiles and the rate to which the profile occurs in TAVR recipients with HALT via a high-throughput precision proteomics platform which utilizes the proximity extension assay (PEA). PEA merges a dual-recognition antibody-based immunoassay with quantitative real-time PCR that allows for the simultaneous quantification of 92 proteins. We will focus on the 5 highest yield panels for the current investigation: cardiovascular II, cardiovascular III, cardiometabolic, inflammation, and oncology II panels. These panels will allow for the assessment of 460 circulating proteins.
- Establish the rate at which these characteristics indicative of future HALT6 months
Using data analysis of baseline patient characteristics to establish the rate that they are indicative of future HALT in patients with aortic stenosis. The sampling frame assumes the sequencing of 460 proteins; a 5% False Discovery Rate; a 10% prognostic prevalence; a minimum fold change of 2; and a normalization ratio of 1.