Optical Tissue Identification for Myocardial Architecture

Phase 2

Active, not recruiting

• Conditions: Ventricular Septal Defect; Complete Atrioventricular Canal; Tetralogy of Fallot With Pulmonary Stenosis
• Interventions: Drug: Fluorescite; Device: Cellvizio 100 Series System with Confocal Miniprobes

• Registration Number: NCT04017975
• Lead Sponsor: Aditya Kaza

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 abnormalities.

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.

Study Timeline

• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-12
• Study Start: 2019-12-20
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imaging cohort	Cellvizio 100 Series System with Confocal Miniprobes	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.
Imaging cohort	Fluorescite	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Residual lesion score (RLS) at discharge	Surgery to discharge (approximately 5 days)	RLS will be compared between groups
Change in QRS interval	Approximately 5 days post-surgery and 1 year post-surgery	QRS interval will be compared between baseline, post-op, and 1 year follow up
Degree of heart block	1 year post-surgery	Degree of heart block will be assessed at post-op and 1 year follow up
Pacemaker implantation	1 year post-surgery	Incidence of temporary and permanent pacemaker implantation will be collected
Time to temporary pacing wire removal prior to discharge	Surgery to discharge (approximately 5 days)	If a temporary pacing wire is placed, time to removal will be collected
Need for repeat bypass	1 day	Need for repeat bypass for residual lesions during surgery will be collected
Adverse events	1 year post-surgery	Rates of adverse events will be collected and compared between the two group
Ease of use	1 day	Surgeon feedback regarding using the FCM system will be collected using a brief survey
Change in PR interval	1 year post-surgery	PR interval will be compared between baseline, post-op, and 1 year follow up
Change in QTc interval	1 year post-surgery	QTc interval will be compared between baseline, post-op, and 1 year follow up

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States