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

• Status: Completed
• Trial end date: 2017-09-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborator: General Electric

Criteria

Inclusion Criteria:

1. Subject must be 18-90 years of age.

2. Subject must have been referred for a clinically indicated CT prior to TAVR.

3. Subject must provide written informed consent prior to any study-related procedures being performed.

4. Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

1. 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.

2. Subject has an acute psychiatric disorder or is cognitively impaired.

3. Subject is using or is dependent on substances of abuse.

4. Subject is unwilling to comply with the requirements of the protocol.

5. Subject has previously entered this study.

6. Subject has an allergy against iodinated contrast agents.

7. Subject is in acute unstable condition.