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The HALT Biomarker Study

RecruitingPhase 1Ages 65 Years - anyAllMassachusetts General Hospital
NCT04552275 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of the HALT Biomarkers study are to identify a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT) and can be used to supplement the diagnosis of HALT; to characterize changes in circulating proteins after treatment of HALT with systemic anticoagulation; and to identify circulating proteins that predict the occurrence of HALT. The study population will be adult patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) or bioprosthetic valve degeneration. Enrollment will continue until 30 patients with HALT are identified for completion of phase 1. Based on a HALT incidence rate of 10%, we anticipate enrolling 300 patients. Patients are enrolled prior to undergoing transfemoral TAVR. Blood samples, clinical data and echocardiograms will be collected a

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age \> 65 years 2. Subject with severe native AS or severe bioprosthetic valve degeneration 3. Subject undergoing transfemoral TAVR using a Medtronic Evolut R, Evolut Pro or Evolut Pro+ transcatheter heart valve Exclusion Criteria: 1. Chronic anticoagulation therapy 2. Contraindication to systemic oral anticoagulation therapy 3. Chronic kidney disease with EGFR\<30 ml/min 4. Bleeding diathesis or known coagulopathy 5. Hypercoagulable state 6. Life-expectancy \<12 months due to other medical conditions (e.g., malignancy, severe Alzheimer's disease, etc.) 7. The patient is currently participating in another investigational device or drug study that has not reached its primary objective/endpoint 8. Pregnant, lactating, or planning pregnancy within next 12 months
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What it tests

  • Proteomics Analysis
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Where

3 sites
Massachusetts General Hospital
Boston, United States
Minneapolis Heart Institute
Minneapolis, United States
Catholic Medical Center
Manchester, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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