Status:
COMPLETED
Aortic Stenosis Pre-Transcatheter Aortic Valve Replacement (TAVR) Procedure CT Scan
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
General Electric
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief 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 minimu...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01843426
Start Date
February 1 2013
End Date
September 25 2017
Last Update
August 2 2018
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425