Status:
COMPLETED
SPY Imaging System: Its Role in Pediatric Cardiac Surgery
Lead Sponsor:
Emory University
Collaborating Sponsors:
Children's Healthcare of Atlanta
Conditions:
Cardiopulmonary Bypass
Congenital Heart Defects
Eligibility:
All Genders
Up to 18 years
Brief Summary
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 he...
Detailed Description
It would be advantageous to detect potential problems with vessel and anastomotic patency prior to leaving the operating room. The SPY imaging system makes use of the fluorescence properties of Indocy...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Known sensitivity to ICG, iodides or shellfish
- Inability to obtain informed consent
- \> 18 years of age
Key Trial Info
Start Date :
April 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00446927
Start Date
April 1 2007
End Date
January 1 2012
Last Update
May 24 2012
Active Locations (1)
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1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322