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Completed

NCT Number: NCT01843426

Aortic Stenosis Pre-Transcatheter Aortic Valve Replacement (TAVR) Procedure CT Scan

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject must be 18-90 years of age.
  • Subject must have been referred for a clinically indicated CT prior to TAVR.
  • Subject must provide written informed consent prior to any study-related procedures being performed.
  • Subject must be willing to comply with all clinical study procedures.

Exclusion criteria

  • Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
  • By testing (serum or urine βHCG) within 24 hours before contrast agent administration, or
  • By surgical sterilization, or
  • Post menopausal, with minimum one (1) year history without menses.
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Clinically Diagnostic CT Assessments

    Time frame: up to 2 years

    Determine that restricting the contrast media volume to 60ml of 270 mgI/ml iodixanol or less generates clinically diagnostic CT assessments prior to TAVR.

Secondary outcomes

  1. Image Quality

    Time frame: up to 2 years

    Measure contrast media attenuation and determine diagnostic image quality within target structures in the aortic root and the ilio-aortic access route.

  2. Safety

    Time frame: up to 2 years

    Evaluate safety and 30-day outcome of patients regarding survival, renal function, and adverse events (renal failure, dialysis, general morbidity).

  3. Long-term Follow-Up

    Time frame: up to 4 years

    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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • General Electric

Registry information

Official study title

Diagnostic Image Quality and Safety of Low-Volume, Low-Concentration, Iso-Osmolar Contrast Medium in the Computed Tomographic Workup of Patients Considered for TAVR

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 30, 2013
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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