Prospective 4D CTA of BAV Competence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT scans.
- Who it may be relevant to
- Registry conditions: Bicuspid. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Diagnostic test CT scans
4D CTA imaging
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Development of aortic insufficiency and/or stenosis. [Time frame: Through study completion, an average of 1 year]
- Development of aortic insufficiency and/or stenosis. [Time frame: Through study completion, an average of 1 year]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT04645862 · 843190