Recruiting

TAVR

Sponsor:

University of Maryland, Baltimore

Code:

NCT05758701

Conditions

Transcatheter Aortic Valve Replacement

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Iodinated Contrast Agent (Omnipaque)

Dual Energy CT

Study Details

Brief summary:

A standard polyenergetic CT (computed tomography) procedure utilizes 100 ml of iodinated contrast. A recent world-wide shortage of iodine based intravenous contrast has highlighted the need to search for alternative methods or doses. Reducing iodinated IV contrast dose can mitigate IV contrast supply shortages and enable significant cost savings for the radiology practice and hospital system. In addition, decreased IV contrast dose can potentially reduce the rate of acute kidney injury, specifically in patients with decreased renal function. The purpose of the study is to determine whether low IV contrast dose CT with monoenergetic reconstruction can be use for presurgical planning of transcatheter valve replacement (TAVR) procedure.

Conditions

Transcatheter Aortic Valve Replacement

Study ID

NCT05758701

Start date

Sep 19, 2023

Status verified date

Jun, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • scheduled to receive TAVR abdominal CT

Exclusion Criteria:

  • cannot undergo CT scan
  • Allergy to intravenous contrast not controlled by steroids or benadryl
  • GFR<30

Study Design

Enrollment

164 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cohort 1

A cohort will be given a 1/3rd reduced dose of iodinated contrast agent (33 ml).

experimental: Cohort 2

If imaging with 1/3 dose is satisfactory, a second cohort with 1/4th the standard dosage (25 ml) will be assessed. If images are not satisfactory, contrast dose will be increased to 50 ml.

Interventions

Iodinated Contrast Agent (Omnipaque)

Standard dosage of Omnipaque for CT imaging is 100 ml. Cohort will be given a reduced dosage.

Dual Energy CT

Dual energy CT scanners enable monoenergetic CT image reconstruction which allows for improved iodine image contrast.

Primary outcome measure

  • Diagnostic Quality of Images [ Time Frame: 18-24 months ]

Central Contacts and Locations

Central contacts

Vikas Kundra, M.D., Ph.D

410-328-3477vkundra@som.umaryland.edu

Rosy Njonkou, M.S.

410-706-0943rnjonkou@som.umaryland.edu

Locations

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Vikas Kundra, MD PhD

vkundra@som.umaryland.edu

Rosy Njonkou

410-706-0943rnjonkou@som.umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Dual energy CT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-07-01.