NCT04645862|Recruiting
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Sponsor study identifier
observational
60
1 country
1
Study Start
December 1, 2020
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 13, 2020
Actual (reported)November 27, 2020
Actual (reported)December 1, 2020
Actual (reported)December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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
4D CTA imaging
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Bicuspid aortic valve identified via clinical imaging
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
First Submitted
November 13, 2020
First Posted
November 27, 2020
Study Start
December 1, 2020
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Tracking of Respiratory-Induced Tumor Motion Using Implanted Fiducials
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
Contact the study team to confirm eligibility.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 6, 2026
Record last verified: 2026-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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