Annual 4D imaging of bicuspid aortic valves
Prospective 4D CTA of BAV Competence
University of Pennsylvania · NCT04645862
This study is testing how 4D imaging can help understand the structure of healthy bicuspid aortic valves in patients to improve future repair surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04645862 on ClinicalTrials.gov |
What this trial studies
This study involves annual 4D computed tomography angiography (CTA) imaging of patients with bicuspid aortic valves (BAV) over a five-year period. The aim is to understand the anatomy of competent BAVs without stenosis or insufficiency, which will help in standardizing BAV repair surgery. Participants will undergo routine echocardiograms and physical assessments alongside the imaging. The study will stratify patients based on the severity of aortic insufficiency at baseline and will analyze anatomical measurements from the scans throughout the cardiac cycle. The imaging will not affect the medical care of participants but will contribute to future evidence-based standards for valve repair candidacy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a documented diagnosis of bicuspid aortic valve and minimal calcification.
Not a fit: Patients who are pregnant, have renal insufficiency, or have a history of severe allergic reactions to intravenous contrast may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical standards and outcomes for patients with bicuspid aortic valves.
How similar studies have performed: While CTA is standard care for BAV patients, this specific 4D imaging approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bicuspid, bicuspid aortic valve