Recruiting

Observational Study

Sponsor:

University of Pennsylvania

Code:

NCT04645862

Conditions

Bicuspid

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CT scans

Study Details

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

Study ID

NCT04645862

Start date

Dec 1, 2020

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Interventions

CT scans

4D CTA imaging

Primary outcome measure

  • Cusp surface areas over the cardiac cycle [ Time Frame: Through study completion, an average of 1 year ]
  • Cusp height (geometric and effective) [ Time Frame: Through study completion, an average of 1 year ]
  • Cusp free margin length [ Time Frame: Through study completion, an average of 1 year ]
  • Cusp thickness (including raphe thickness, if applicable) [ Time Frame: Through study completion, an average of 1 year ]
  • Commissural height [ Time Frame: Through study completion, an average of 1 year ]
  • Sino tubular junction size [ Time Frame: Through study completion, an average of 1 year ]
  • Size of the sinuses of Valsalva [ Time Frame: Through study completion, an average of 1 year ]
  • Ventriculoaortic junction size [ Time Frame: Through study completion, an average of 1 year ]
  • Aortic annulus size [ Time Frame: Through study completion, an average of 1 year ]
  • Coaptation height at diastole [ Time Frame: Through study completion, an average of 1 year ]
  • Cusp displacement over the cardiac cycle [ Time Frame: Through study completion, an average of 1 year ]
  • Cusp velocity over the cardiac cycle [ Time Frame: Through study completion, an average of 1 year ]
  • Size of the ascending aorta [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Jessica Nunez

215-829-3712Jessica.Nunez@pennmedicine.upenn.edu

Kamryn Delaney

Kamryn.Delaney@pennmedicine.upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Keywords

  • bicuspid aortic valve

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-02-06.