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NCT Number: NCT04017975

Optical Tissue Identification for Myocardial Architecture

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ventricular Septal Defect Cardiovascular Abnormalities Cardiovascular Diseases Complete Atrioventricular Canal Complete atrioventricular septal defect Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Ventricular Tetralogy of Fallot With Pulmonary Stenosis

Age range

30 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluorescite

Drug

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

Cellvizio 100 Series System with Confocal Miniprobes

Device

The microscopy system will image cardiac tissue.

Primary outcomes

  1. 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 outcomes

  1. Change in PR interval

    Time frame: 1 year post-surgery

    PR interval will be compared between baseline, post-op, and 1 year follow up

  2. Change in QTc interval

    Time frame: 1 year post-surgery

    QTc interval will be compared between baseline, post-op, and 1 year follow up

  3. 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

  4. 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

  5. Pacemaker implantation

    Time frame: 1 year post-surgery

    Incidence of temporary and permanent pacemaker implantation will be collected

  6. 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

  7. Residual lesion score (RLS) at discharge

    Time frame: Surgery to discharge (approximately 5 days)

    RLS will be compared between groups

  8. Need for repeat bypass

    Time frame: 1 day

    Need for repeat bypass for residual lesions during surgery will be collected

  9. Adverse events

    Time frame: 1 year post-surgery

    Rates of adverse events will be collected and compared between the two group

  10. Ease of use

    Time frame: 1 day

    Surgeon feedback regarding using the FCM system will be collected using a brief survey

Sponsors and collaborators

Lead sponsor

Aditya Kaza

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Optical Tissue Identification for Myocardial Architecture (OPTIMA Study)

Acronym: OPTIMA

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2019
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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