Transcatheter Aortic Valve ReplacementPhase 4CT TAVRNCT05758701
CT TAVR Abdomen Study
A Phase 4 study testing Iodinated Contrast Agent (Omnipaque) and Dual Energy CT in people with Transcatheter Aortic Valve Replacement, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcatheter Aortic Valve Replacement
- What is being tested?
- Iodinated Contrast Agent (Omnipaque) and Dual Energy CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2023to 1 Mar 2028
- Phase
- Phase 4
- 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 to 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- scheduled to receive TAVR abdominal CT
Who cannot join
- cannot undergo CT scan
- Allergy to intravenous contrast not controlled by steroids or benadryl
- GFR<30
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 Maryland Medical Center
Baltimore, Maryland, 21201
Vikas Kundra, MD PhD, vkundra@som.umaryland.edu
Rosy Njonkou, 410-706-0943, rnjonkou@som.umaryland.edu
About this study
Official title: Dual Energy CT Decreased IV Contrast Dose Imaging for TAVR
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
- Being tested
- Iodinated Contrast Agent (Omnipaque), Dual Energy CT
- Keywords
- Dual energy CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodinated Contrast Agent (Omnipaque)Combination product
Standard dosage of Omnipaque for CT imaging is 100 ml. Cohort will be given a reduced dosage.
Dual Energy CTDevice
Dual energy CT scanners enable monoenergetic CT image reconstruction which allows for improved iodine image contrast.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | A cohort will be given a 1/3rd reduced dose of iodinated contrast agent (33 ml). Receives: Combination Product: Iodinated Contrast Agent (Omnipaque); Device: Dual Energy CT |
| Cohort 2 | Experimental | 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. Receives: Combination Product: Iodinated Contrast Agent (Omnipaque); Device: Dual Energy CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Quality of Images
5-point Likert Scale
Measured: 18-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start19 Sep 2023
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transcatheter Aortic Valve ReplacementStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- In a standard polyenergetic CT procedure, 100 ml of iodinated contrast is used. Two cohorts of patients will be assessed, the first being given a 1/3rd reduction (33 ml). If satisfactory, a second cohort with 1/4th the standard dosage (25 ml) will be assessed. If unsatisfactory, the IV contrast dose will be increased to 1/2 (50 ml)
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vikas Kundra, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758701
- Sponsor's protocol ID
- HP-00104800
- Acronym
- CT TAVR
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2023
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schoenhagen P, Hausleiter J, Achenbach S, Desai MY, Tuzcu EM. Computed tomography in the evaluation for transcatheter aortic valve implantation (TAVI). Cardiovasc Diagn Ther. 2011 Dec;1(1):44-56. doi: 10.3978/j.issn.2223-3652.2011.08.01.
PubMed 24282684Gurm HS, Dixon SR, Smith DE, Share D, Lalonde T, Greenbaum A, Moscucci M; BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) Registry. Renal function-based contrast dosing to define safe limits of radiographic contrast media in patients undergoing percutaneous coronary interventions. J Am Coll Cardiol. 2011 Aug 23;58(9):907-14. doi: 10.1016/j.jacc.2011.05.023.
PubMed 21851878
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Energy CT Decreased IV Contrast Dose Imaging for TAVR
- ClinicalTrials.gov ID
- NCT05758701
- Acronym / sponsor ID
- CT TAVR / HP-00104800
- Conditions
- Transcatheter Aortic Valve Replacement
- Keywords
- Dual energy CT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 7 Mar 2023 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In a standard polyenergetic CT procedure, 100 ml of iodinated contrast is used. Two cohorts of patients will be assessed, the first being given a 1/3rd reduction (33 ml). If satisfactory, a second cohort with 1/4th the standard dosage (25 ml) will be assessed. If unsatisfactory, the IV contrast dose will be increased to 1/2 (50 ml)
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Combination Product: Iodinated Contrast Agent (Omnipaque), Device: Dual Energy CTA cohort will be given a 1/3rd reduced dose of iodinated contrast agent (33 ml). |
| Cohort 2 | Experimental | Combination Product: Iodinated Contrast Agent (Omnipaque), Device: Dual Energy CTIf 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. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- scheduled to receive TAVR abdominal CT
Key exclusion criteria (3 listed)
- cannot undergo CT scan
- Allergy to intravenous contrast not controlled by steroids or benadryl
- GFR<30
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 |
|---|---|---|
| Iodinated Contrast Agent (Omnipaque)Standard dosage of Omnipaque for CT imaging is 100 ml. Cohort will be given a reduced dosage. | Combination product | Cohort 1, Cohort 2 |
| Dual Energy CTDual energy CT scanners enable monoenergetic CT image reconstruction which allows for improved iodine image contrast. | Device | Cohort 1, Cohort 2 |
Primary outcome
Diagnostic Quality of Images
Time frame: 18-24 months
5-point Likert Scale
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 1 Jul 2026.
- Background: PubMed 24282684Schoenhagen P, Hausleiter J, Achenbach S, Desai MY, Tuzcu EM. Computed tomography in the evaluation for transcatheter aortic valve implantation (TAVI). Cardiovasc Diagn Ther. 2011 Dec;1(1):44-56. doi: 10.3978/j.issn.2223-3652.2011.08.01.
- Background: PubMed 21851878Gurm HS, Dixon SR, Smith DE, Share D, Lalonde T, Greenbaum A, Moscucci M; BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) Registry. Renal function-based contrast dosing to define safe limits of radiographic contrast media in patients undergoing percutaneous coronary interventions. J Am Coll Cardiol. 2011 Aug 23;58(9):907-14. doi: 10.1016/j.jacc.2011.05.023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iodinated Contrast Agent (Omnipaque) and Dual Energy CT in people with Transcatheter Aortic Valve Replacement, run by University of Maryland, Baltimore 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 1 inclusion and 3 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 1 Jul 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Vikas Kundra, M.D., Ph.D (410-328-3477, vkundra@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Quality of Images (time frame: 18-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05758701, which also lists 2 linked publications.
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 1 Jul 2026.