Summary
The goal of this study is to test the hypothesis that fiberoptic confocal microscopy (FCM) imaging during repair of common congenital heart defects is a useful adjunct for avoidance of conduction abnormalities.
Conditions
Ventricular Septal Defect, Complete Atrioventricular Canal, Tetralogy of Fallot With Pulmonary Stenosis
Recruitment Status
Active, not recruiting
Detailed Description
This is an interventional randomized controlled study to investigate the use of fiberoptic confocal microscopy (FCM) imaging for avoidance of conduction abnormalities during repair of common congenital heart defects. Study results will be compared to a cohort of similar surgical patients following standard surgical procedures where FCM was not used. We will analyze pre-and postoperative ECGs to identify conduction abnormalities.
Eligibility Criteria
Inclusion Criteria:
Age 30 days to less than 18 years old
Patients with planned surgical repair of:
Ventricular septal defect (VSD)
Complete atrioventricular canal (CAVC)
Tetralogy of Fallot (ToF) with pulmonary stenosis
Exclusion Criteria:
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 > 98% for age
Underlying genetic syndrome associated with progressive AV block or sinus node dysfunction (e.g. Holt-Oram or NKX2.5)
Any surgical repair that requires staging or palliation
Pregnant or lactating
Exclusions specific to type of surgical repair
Apical muscular VSD
ToF with pulmonary atresia
Intervention
Intervention Type
Intervention Name
Drug
Fluorescite
Device
Cellvizio 100 Series System with Confocal Miniprobes
Phase
Phase 2
Gender
All
Min Age
30 Days
Max Age
18 Years
Download Date
June 15, 2023
Principal Investigator
Aditya Kaza
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: