The HALT Biomarker Study

Launched by MASSACHUSETTS GENERAL HOSPITAL · Sep 11, 2020

Keywords

ClinConnect Summary

The HALT Biomarker Study is looking to identify specific proteins in the blood that can help doctors tell if a patient has a condition called Hypo-Attenuated Leaflet Thickening (HALT), which can occur in people with severe aortic stenosis or certain types of heart valves. The study aims to help improve the diagnosis of HALT and understand how treatment affects these proteins over time. Researchers will enroll around 300 adult patients who are 65 years or older and are preparing for a procedure called transcatheter aortic valve replacement (TAVR). Participants will have their blood tested and undergo heart scans at different times: before the procedure, after the procedure, and again in follow-ups at 30 days and 6 months.

If you are eligible for the study, you should not be on chronic blood-thinning medication, have certain kidney conditions, or be pregnant. During the study, blood samples will be collected, and if you have HALT, you may receive treatment to help manage it. This study is currently recruiting participants and is the first phase of a larger effort to better understand this condition and potentially improve treatment options in the future.

Gender

ALL

Eligibility criteria

• 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