Prospective 4D CTA of BAV Competence
The study involves annual 4D CTA imaging of the bicuspid aortic valve for a period of 5 years. CTA is often standard of care for BAV patients, but patients in this study will receive a higher radiation dose with a 4D imaging protocol. There may also be patients enrolled in the study who have a 4D CTA for research purposes when a routine CTA is not required for clinical care.
Conditions:
🦠 Bicuspid
🗓️ Study Start (Actual) 1 December 2020
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 60
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * At least 18 years of age
    • * Documented bicuspid aortic valve identified via clinical imaging (e.g., CT, MRI, or echocardiogram) with minimal calcification at the time of enrollment
    • * Participant must sign the informed consent form

    Exclusion Criteria:

    • * Pregnancy (determined by point of care urine pregnancy test)
    • * Renal failure (estimated Glomerular Filtration Rate (eGFR) \< 30), precluding them from receiving intravenous contrast)
    • * Documentation of previous intravenous contrast allergy (unless they are having a CT with steroid preparation as part of routine clinical care)
    • * Previous aortic valve replacement
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 November 2020
  • First Submitted that Met QC Criteria 19 November 2020
  • First Posted 27 November 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 April 2024
  • Last Update Posted 25 April 2024
  • Last Verified April 2024