SPY Imaging System: Its Role in Pediatric Cardiac Surgery

Completed

Conditions studied: Cardiopulmonary Bypass, Congenital Heart Defects

In brief

The current method of evaluating the surgical repair during surgery is limited to echocardiography (a noninvasive diagnostic procedure that uses ultrasound to study the structure and motions of the heart) or an invasive procedure called cardiac catheterization. The SPY imaging system makes use of the fluorescence properties of indocyanine green (ICG) to obtain high quality images in blood vessels. ICG is a green dye used to test heart output. The use of the SPY imaging system during surgery may provide valuable information regarding successful vessel connection and the area remaining unblocked. This study will compare the results of images to echocardiography and conventional angiography results. With SPY imaging, congenital heart surgeons would be able to check the quality of the procedure and revise, redo or perform additional procedures as dictated by the images before the patient leaves the operating room.

Key facts

Study ID

NCT00446927

Run by

Emory University

People needed

40

Starts

2007-04-01

Expected to finish

2012-01-01

Last updated by the study team

2012-05-24

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing congenital heart operations at Children's Healthcare of Atlanta.
• Less than or equal to 18 years of age.
• Arterial switch procedure
• Anomalous coronary artery from the pulmonary artery repair
• Aortic root replacement
• Coarctation of the aorta repair
• Blalock-Taussig shunt
• Right ventricle-to-pulmonary artery shunt
• Cavopulmonary shunt
• Branch or distal pulmonary artery reconstruction
• Unifocalization of aortopulmonary collaterals

You may not qualify if…

• Known sensitivity to ICG, iodides or shellfish
• Inability to obtain informed consent
• > 18 years of age

Where it is running

• Children's Healthcare of Atlanta — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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