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NCT Number: NCT04645862

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.

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Key information

Conditions

Bicuspid Aortic Valve Disease Bicuspid Aortic Valve Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Alison Pouch

SUB_INVESTIGATOR

Jessica Nunez

CONTACT

[email protected]

215-829-3712

Kamryn Delaney

CONTACT

[email protected]

About this study

The bicuspid aortic valve (BAV) is the most common congenital heart disease. The purpose of this study is to better understand the anatomy of physiologically normal, or competent, BAVs without stenosis or insufficiency (AI) in order to support evidence-based standardization of BAV repair surgery. Men and women over 18 years of age with a diagnosis of BAV and minimal aortic valve calcification at baseline will undergo annual 4D computed tomography angiography (CTA) scans, routine transthoracic echocardiograms, and history and physical assessments over the course of the 5-year study period. Patients who are pregnant, have renal insufficiency (creatinine 2 mg/dL), or who have a contraindication to intravenous contrast will be excluded. Patients will be stratified into study groups according to baseline AI: approximately half of patients will have no to mild AI at baseline and the other half will have moderate to severe AI at baseline. Anatomical measurements will be obtained from the 4D CTA scans and analyzed at each phase of the cardiac cycle, as well as longitudinally. The 4D CTA imaging and analysis will not impact medical care of the study participants; the anatomical measurements will be used in the future as evidence-based standards for determining valve repair candidacy for BAV patients with AI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT scans

Diagnostic Test

4D CTA imaging

Primary outcomes

  1. Cusp surface areas over the cardiac cycle

    Time frame: Through study completion, an average of 1 year

    Surface area of each cusp in mm2 in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.

  2. Cusp height (geometric and effective)

    Time frame: Through study completion, an average of 1 year

    Geometric and effective cusp height in mm in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.

  3. Cusp free margin length

    Time frame: Through study completion, an average of 1 year

    Length of the free margin of each cusp in mm in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.

  4. Cusp thickness (including raphe thickness, if applicable)

    Time frame: Through study completion, an average of 1 year

    Thickness of each cusp in mm in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.

  5. Commissural height

    Time frame: Through study completion, an average of 1 year

    Height of each commissure in mm in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.

  6. Sino tubular junction size

    Time frame: Through study completion, an average of 1 year

    Diameter of the sinotubular junction in mm in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.

  7. Size of the sinuses of Valsalva

    Time frame: Through study completion, an average of 1 year

    Maximum diameter of the sinuses of Valsalva (mid-level of the aortic root) in mm in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.

  8. Ventriculoaortic junction size

    Time frame: Through study completion, an average of 1 year

    Diameter of the ventriculoaortic junction in mm in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.

  9. Aortic annulus size

    Time frame: Through study completion, an average of 1 year

    Diameter of the aortic cusp in mm measured in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.

  10. Coaptation height at diastole

    Time frame: Through study completion, an average of 1 year

    Length of the coaptation zone of the cusps in mm when the valve is closed. This measurement is made in one cardiac cycle (~0.6 - 1s in length) from the CT image.

  11. Cusp displacement over the cardiac cycle

    Time frame: Through study completion, an average of 1 year

    Total displacement of the center of the free margin of each cusp in mm during one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.

  12. Cusp velocity over the cardiac cycle

    Time frame: Through study completion, an average of 1 year

    Maximum velocity of the center of the free margin of each cusp in mm/s during one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.

  13. Size of the ascending aorta

    Time frame: Through study completion, an average of 1 year

    Maximum diameter of the ascending aorta in cm during one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.

Secondary outcomes

  1. Development of aortic insufficiency and/or stenosis.

    Time frame: Through study completion, an average of 1 year

    Degree of aortic insufficiency as measured on standard-of-care echocardiography

  2. Development of aortic insufficiency and/or stenosis.

    Time frame: Through study completion, an average of 1 year

    The need for surgical intervention for disease of the aortic valve and/or ascending aorta

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Nov 27, 2020
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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