Optical Tissue Identification for Myocardial Architecture (OPTIMA)

Optical Tissue Identification for Myocardial Architecture (OPTIMA Study)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Complete Atrioventricular Canal; Ventricular Septal Defect; Tetralogy of Fallot With Pulmonary Stenosis
• Intervention / Treatment: Drug: Fluorescite; Device: Cellvizio 100 Series System with Confocal Miniprobes

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Non-imaging cohort; There will be no intervention for the non-imaging group. Subjects will receive standard of care for cardiac surgery.
Experimental: Imaging cohort; 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; 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.; Other Names: fluorescein sodium; Device: Cellvizio 100 Series System with Confocal Miniprobes; The microscopy system will image cardiac tissue.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aditya Kaza
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Aditya K Kaza, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2019
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: cardiac surgery; fiberoptic confocal microscopy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Valve Diseases; Ventricular Outflow Obstruction; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects; Tetralogy of Fallot; Pulmonary Valve Stenosis; Heart Septal Defects, Ventricular
• Other Study ID Numbers: P00031701; R56HL128813 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes