Optical Tissue Identification for Myocardial Architecture

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.

Full Title of Study: “Optical Tissue Identification for Myocardial Architecture (OPTIMA Study)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 2023

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Days

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aditya Kaza
  • Collaborator
    • National Heart, Lung, and Blood Institute (NHLBI)
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Aditya Kaza, Associate in Cardiac Surgery – Boston Children’s Hospital
  • Overall Official(s)
    • Aditya K Kaza, MD, Principal Investigator, Boston Children’s Hospital

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