BicuspidNCT04645862
Prospective 4D CTA of BAV Competence
An observational study of Bicuspid, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bicuspid
- What is being tested?
- CT scans
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bicuspid aortic valve identified via clinical imaging
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Jessica Nunez, 215-829-3712, Jessica.Nunez@pennmedicine.upenn.edu
Kamryn Delaney, Kamryn.Delaney@pennmedicine.upenn.edu
About this study
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.
Read the 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.
- Conditions
- Bicuspid
- Being tested
- CT scans
- Keywords
- bicuspid aortic valve
- Medical subject headings
- Bicuspid Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scansDiagnostic test
4D CTA imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Development of aortic insufficiency and/or stenosis.
Degree of aortic insufficiency as measured on standard-of-care echocardiography
Measured: Through study completion, an average of 1 year
Development of aortic insufficiency and/or stenosis.
The need for surgical intervention for disease of the aortic valve and/or ascending aorta
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start1 Dec 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BicuspidStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645862
- Sponsor's protocol ID
- 843190
- Status last verified
- Feb 2026
- First submitted
- 13 Nov 2020
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective 4D CTA of BAV Competence
- ClinicalTrials.gov ID
- NCT04645862
- Acronym / sponsor ID
- 843190
- Conditions
- Bicuspid
- Keywords
- bicuspid aortic valve
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bicuspid aortic valve identified via clinical imaging
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scans4D CTA imaging | Diagnostic test | – |
Primary outcome
Cusp surface areas over the cardiac cycle
Time frame: Through study completion, an average of 1 year
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.
Cusp height (geometric and effective)
Time frame: Through study completion, an average of 1 year
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.
Cusp free margin length
Time frame: Through study completion, an average of 1 year
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.
Cusp thickness (including raphe thickness, if applicable)
Time frame: Through study completion, an average of 1 year
Thickness of each cusp in mm in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.
Commissural height
Time frame: Through study completion, an average of 1 year
Height of each commissure in mm in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.
Sino tubular junction size
Time frame: Through study completion, an average of 1 year
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.
Size of the sinuses of Valsalva
Time frame: Through study completion, an average of 1 year
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.
Ventriculoaortic junction size
Time frame: Through study completion, an average of 1 year
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.
Aortic annulus size
Time frame: Through study completion, an average of 1 year
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.
Coaptation height at diastole
Time frame: Through study completion, an average of 1 year
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.
Cusp displacement over the cardiac cycle
Time frame: Through study completion, an average of 1 year
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.
Cusp velocity over the cardiac cycle
Time frame: Through study completion, an average of 1 year
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.
Size of the ascending aorta
Time frame: Through study completion, an average of 1 year
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Bicuspid
Not yet recruiting
Anesthetic Effectiveness of Mental/Incisive Nerve Block Versus Inferior Nerve Block Using 4% Articaine and 2% Lidocaine in Mandibular First and Second Premolars With Symptomatic Irreversible Pulpitis.
Pain
Active, not recruiting
Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)
Aortic Stenosis With Bicuspid Valve
Enrolling by invitationObservational study
Bicuspid Aortic Valve (BAV) Registry
Bicuspid Aortic Valve
Enrolling by invitation
Evaluation of Corticotomy-Assisted Canine Retraction Rate
Malocclusion, Corticotomy
Active, not recruiting
Sleeved vs. Sleeveless Guides for Immediate Implant Placement
Tooth Loss, Maxillary Premolar Area
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of Pennsylvania
Philadelphia, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bicuspid, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cusp surface areas over the cardiac cycle (time frame: Through study completion, an average of 1 year). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.