Optical Tissue Identification for Myocardial Architecture

Aditya Kaza70 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Ventricular Septal Defect Complete Atrioventricular Canal Tetralogy of Fallot With Pulmonary Stenosis

Interventions

FluoresciteDRUG

1 mL of Fluorescite will be diluted into 1L of saline. Up to 5mLs of the 1:1000 diluted solution will be applied topically to the cardiac tissue prior to imaging.

Cellvizio 100 Series System with Confocal MiniprobesDEVICE

The microscopy system will image cardiac tissue.

Eligibility

Sex: ALLMin age: 30 DaysMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Rate of new conduction disorders

Rate of new conduction disorders post-surgery will be determined by electrophysiologist read and compared between the two groups

Time frame: Immediately post-surgery

Secondary Outcomes

Change in PR interval

PR interval will be compared between baseline, post-op, and 1 year follow up

Time frame: 1 year post-surgery

Change in QTc interval

QTc interval will be compared between baseline, post-op, and 1 year follow up

Time frame: 1 year post-surgery

Change in QRS interval

QRS interval will be compared between baseline, post-op, and 1 year follow up

Time frame: Approximately 5 days post-surgery and 1 year post-surgery

Degree of heart block

Degree of heart block will be assessed at post-op and 1 year follow up

Time frame: 1 year post-surgery

Pacemaker implantation

Incidence of temporary and permanent pacemaker implantation will be collected

Time frame: 1 year post-surgery

Time to temporary pacing wire removal prior to discharge

If a temporary pacing wire is placed, time to removal will be collected

Time frame: Surgery to discharge (approximately 5 days)

Residual lesion score (RLS) at discharge

RLS will be compared between groups

Data from ClinicalTrials.gov

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