Utilization of Confocal Microscopy During Cardiac Surgery

Completed · Phase 1

Conditions studied: Atrial Septal Defect

In brief

The investigators propose to translate confocal microscopy for use during open heart surgery. This tool will help discriminate between various types of tissues in the heart during surgery. One of the most feared complication after heart surgery is heart block. This flexible fiberoptic confocal microscope will help discriminate between the various types of tissues in the heart and thus help avoid injury to the conduction tissue during surgery.

Key facts

Study ID

NCT03189134

Run by

Aditya Kaza

People needed

6

Starts

2018-04-02

Expected to finish

2019-04-26

Last updated by the study team

2020-07-07

Who can join

Age: 0 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females between 30 days and 21 years old
• Undergoing elective surgery for closure of atrial septal defect
• Both parents attend pre-operative clinic appointment, to provide 2 parent consent, or an adult participant (age 18-21) may provide consent for him/herself

You may not qualify if…

• Prior history of adverse reaction to fluorescein sodium
• Prior history of renal failure or abnormal renal function
• Baseline PR interval > 220 msec or 98% for age
• Baseline HR > 87% for age
• Underlying genetic syndrome associated with progressive AV block of sinus node dysfunction (e.g. Holt-Oram or NKX2.5)

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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