Optical Tissue Identification for Myocardial Architecture

Ventricular Septal Defect Clinical Trial

— OPTIMA  

Official title:

Optical Tissue Identification for Myocardial Architecture (OPTIMA Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04017975
• Other study ID #: P00031701
• Secondary ID: R56HL128813
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 20, 2019
• Est. completion date: September 2023

Study information

• Verified date: June 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Days to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Complete Atrioventricular Canal
• Heart Septal Defects, Ventricular
• Pulmonary Valve Stenosis
• Tetralogy of Fallot
• Tetralogy of Fallot With Pulmonary Stenosis
• Ventricular Septal Defect

Intervention

Drug:
• Fluorescite
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.

Device:
• Cellvizio 100 Series System with Confocal Miniprobes
The microscopy system will image cardiac tissue.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

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