Optical Tissue Identification for Myocardial Architecture

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aditya Kaza
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

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