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

NCT01843426 | Completed

• 1 other identifier: Pro19770
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 minimum volume of contrast material that can be used to ensure patient safety while not compromising diagnostic image quality in high-risk patients.

Conditions

Aortic Valve Stenosis

Keywords

Comorbidity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Image Quality

  up to 2 years

• Safety

  up to 2 years

• Long-term Follow-Up

  up to 4 years

Study Arms (1)

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.

Drug: Low-volume, low-concentration contrast (iodixanol - Visipaque 270) CT scan

Interventions

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.

Low-volume, Low-concentration contrast (Visipaque 270) CT scan

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• General Electric: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Joseph Schoepf, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: April 30, 2013
• Study Start: February 1, 2013
• Primary Completion: September 25, 2017
• Study Completion: September 25, 2017
• Last Updated: August 2, 2018

Record last verified: 2018-03

Locations

US (1)