Optical Tissue Identification for Myocardial Architecture

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Optical Tissue Identification for Myocardial Architecture (OPTIMA Study)

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

Intervention / Treatment
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* Drug: Fluorescite
* Device: Cellvizio 100 Series System with Confocal Miniprobes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Days
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized into two groups using permuted block and stratified according to type of surgical repair.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non-imaging cohort<br>There will be no intervention for the non-imaging group. Subjects will receive standard of care for cardiac surgery. | |
| Experimental: Imaging cohort<br>Up to 5mL of 1:1000 dilute fluorescite will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes. The system will be used to assist the investigator with the operative course. | Drug: Fluorescite<br>* 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.<br>* Other names: fluorescein sodium;Device: Cellvizio 100 Series System with Confocal Miniprobes<br>* The microscopy system will image cardiac tissue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of new conduction disorders | Rate of new conduction disorders post-surgery will be determined by electrophysiologist read and compared between the two groups | Immediately post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PR interval | PR interval will be compared between baseline, post-op, and 1 year follow up | 1 year post-surgery | 
| Change in QTc interval | QTc interval will be compared between baseline, post-op, and 1 year follow up | 1 year post-surgery | 
| Change in QRS interval | QRS interval will be compared between baseline, post-op, and 1 year follow up | 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 | 1 year post-surgery | 
| Pacemaker implantation | Incidence of temporary and permanent pacemaker implantation will be collected | 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 | Surgery to discharge (approximately 5 days) | 
| Residual lesion score (RLS) at discharge | RLS will be compared between groups | Surgery to discharge (approximately 5 days) | 
| Need for repeat bypass | Need for repeat bypass for residual lesions during surgery will be collected | 1 day | 
| Adverse events | Rates of adverse events will be collected and compared between the two group | 1 year post-surgery | 
| Ease of use | Surgeon feedback regarding using the FCM system will be collected using a brief survey | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fiberoptic confocal microscopy, cardiac surgery