Prospective 4D CTA of BAV Competence

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: Recruiting
• Conditions: Bicuspid
• Intervention / Treatment: Diagnostic test: CT scans

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: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Sub-Investigator: Alison Pouch
      • Contact: Jessica Nunez; Phone Number: 215-829-3712; Email: Jessica.Nunez@pennmedicine.upenn.edu
      • Contact: Kamryn Delaney; Email: Kamryn.Delaney@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of aortic insufficiency and/or stenosis.	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.	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

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: bicuspid aortic valve
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bicuspid Aortic Valve Disease; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Radiography; Image Interpretation, Computer-Assisted; Radiographic Image Enhancement; Image Enhancement; Photography; Tomography, X-Ray; Tomography, X-Ray Computed
• Other Study ID 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