Current Environment:

Alert

ENFit Feeding Tube Adapters

GI Feeding Tube Users: if you do not have ENFit tubes, you may need an adapter to deliver feeds or medications. Contact your pharmacy or home care company.

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

April 5, 2022

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: