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| Name | Class |
|---|---|
| General Electric | INDUSTRY |
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The purpose of this study is to evaluate contrast media volume, safety and 30-day outcome of patients after a computed tomography (CT) scan. The results of this study will help to determine the minimum volume of contrast material that can be used to ensure patient safety while not compromising diagnostic image quality in high-risk patients.
The scholarly rationale for the study is to determine the feasibility of restricting the contrast media volume to 60ml of 270mg Iodine (mgI)/ml iodixanol or less to accomplish sufficient intravascular attenuation for comprehensive CT assessment prior to TAVR. The study will also evaluate the effects of contrast media administration on our subjects' kidney function by performing serum creatinine measurements at baseline, as well as at three days and thirty days after contrast media administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-volume, Low-concentration contrast (Visipaque 270) CT scan | Experimental | An ECG-synchronized, contrast-medium enhanced CT study of the heart for the evaluation of the aortic root complex and general cardiac morphology will be obtained. This is immediately followed by a CT angiographic study of the chest, abdomen, and pelvis (beyond the femoral heads), which utilizes the same contrast bolus that is injected for evaluating the heart. This latter vascular study serves to evaluate the TAVR deployment catheter access route through the femoral, iliac, and aortic vascular stations. In clinical routine, we have been performing this type of study with total contrast media volumes ranging from 40-120 mL of iodinated contrast material. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-volume, low-concentration contrast (iodixanol - Visipaque 270) CT scan | Drug | An ECG-synchronized, contrast-medium enhanced CT study of the heart for the evaluation of the aortic root complex and general cardiac morphology will be obtained. This is immediately followed by a CT angiographic study of the chest, abdomen, and pelvis (beyond the femoral heads), which utilizes the same contrast bolus that is injected for evaluating the heart. This latter vascular study serves to evaluate the TAVR deployment catheter access route through the femoral, iliac, and aortic vascular stations. In clinical routine, we have been performing this type of study with total contrast media volumes ranging from 40-120 mL of iodinated contrast material. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically Diagnostic CT Assessments | Determine that restricting the contrast media volume to 60ml of 270 mgI/ml iodixanol or less generates clinically diagnostic CT assessments prior to TAVR. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Image Quality | Measure contrast media attenuation and determine diagnostic image quality within target structures in the aortic root and the ilio-aortic access route. | up to 2 years |
| Safety | Evaluate safety and 30-day outcome of patients regarding survival, renal function, and adverse events (renal failure, dialysis, general morbidity). |
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Inclusion Criteria:
Exclusion Criteria:
Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
Subject has an acute psychiatric disorder or is cognitively impaired.
Subject is using or is dependent on substances of abuse.
Subject is unwilling to comply with the requirements of the protocol.
Subject has previously entered this study.
Subject has an allergy against iodinated contrast agents.
Subject is in acute unstable condition.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Schoepf, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| up to 2 years |
| Long-term Follow-Up | Determine procedural outcome of the TAVR procedure by longer-term patient follow-up after one and two years for device function, position, and paravalvular leakage. | up to 4 years |
| D014694 |
| Ventricular Outflow Obstruction |