F-18 NaF PET-CT for Assessment of Bioprosthetic Aortic Valve Durability & Outcomes

Condition: Aortic stenosis

Eligibility

Key Inclusion Criteria

  • At least 60 years old
  • Between one month and five years following transcatheter aortic valve replacement or surgical bioprosthetic aortic valve replacement

Key Exclusion Criteria

  • History of severe allergy to iodine contrast agents
  • Pregnant or breastfeeding
  • Active atrial fibrillation

Full Study Name

18-F Sodium Fluoride (18F-NaF) Positron Emission Tomography (PET) for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes (IRB no. 46429)

Summary

This study focuses on patients who have undergone a transcatheter aortic valve replacement (TAVR) or surgical bioprosthetic aortic valve replacement as part of standard of care. The narrowing of the main outlet valve of the heart (aortic stenosis) due to a build-up of calcium deposits is a common form of heart valve disease. Recently, the TAVR procedure has been developed to replace the aortic valve with a bioprosthetic tissue valve using a minimally invasive technique. The purpose of this study is to determine whether a combined positron emission tomography and computed tomography (PET-CT) heart scan using a radioactive tracer, sodium fluoride, can provide information regarding the durability of valves replaced using the TAVR procedure and conventionally placed valves. The use of sodium fluoride in this study is investigational.


Principal Investigator

Daniel Berman, MD

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