Status:
UNKNOWN
Optical Tissue Identification for Myocardial Architecture
Lead Sponsor:
Aditya Kaza
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Ventricular Septal Defect
Complete Atrioventricular Canal
Eligibility:
All Genders
30-18 years
Phase:
PHASE2
Brief 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 abno...
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 congenita...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04017975
Start Date
December 20 2019
End Date
September 1 2023
Last Update
June 15 2023
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115