Prospective 4D CTA of BAV Competence

NCT04645862 | Recruiting

• 1 other identifier: 843190
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

bicuspid aortic valve

Outcome Measures

Primary Outcomes (13)

• Cusp surface areas over the cardiac cycle

  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.

  Through study completion, an average of 1 year

• Cusp height (geometric and effective)

  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.

  Through study completion, an average of 1 year

• Cusp free margin length

  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.

  Through study completion, an average of 1 year

• Cusp thickness (including raphe thickness, if applicable)

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

  Through study completion, an average of 1 year

• Commissural height

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

  Through study completion, an average of 1 year

• Sino tubular junction size

  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.

  Through study completion, an average of 1 year

• Size of the sinuses of Valsalva

  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.

  Through study completion, an average of 1 year

• Ventriculoaortic junction size

  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.

  Through study completion, an average of 1 year

• Aortic annulus size

  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.

  Through study completion, an average of 1 year

• Coaptation height at diastole

  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.

  Through study completion, an average of 1 year

• Cusp displacement over the cardiac cycle

  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.

  Through study completion, an average of 1 year

• Cusp velocity over the cardiac cycle

  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.

  Through study completion, an average of 1 year

• Size of the ascending aorta

  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.

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Development of aortic insufficiency and/or stenosis.

  Through study completion, an average of 1 year

• Development of aortic insufficiency and/or stenosis.

  Through study completion, an average of 1 year

Interventions

CT scans DIAGNOSTIC_TEST

4D CTA imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Bicuspid aortic valve identified via clinical imaging

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Bicuspid Aortic Valve Disease

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 27, 2020
• Study Start: December 1, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (1)