Prospective 4D CTA of BAV Competence

February 5, 2026 updated by: University of Pennsylvania
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Bicuspid aortic valve identified via clinical imaging

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
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
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
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Development of aortic insufficiency and/or stenosis.
Time Frame: Through study completion, an average of 1 year
Degree of aortic insufficiency as measured on standard-of-care echocardiography
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
The need for surgical intervention for disease of the aortic valve and/or ascending aorta
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 843190

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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