Complete Atrioventricular Canal, Tetralogy of Fallot With Pulmonary Stenosis, Ventricular Septal Defect
Conditions
Keywords
fiberoptic confocal microscopy, cardiac surgery
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.
Interventions
DRUGFluorescite
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.
The microscopy system will image cardiac tissue.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Aditya Kaza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Subjects and the physician reading ECGs will be blinded.
Intervention model description
Subjects will be randomized into two groups using permuted block and stratified according to type of surgical repair.
Eligibility
Sex/Gender
ALL
Age
30 Days to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in QTc interval | 1 year post-surgery | QTc interval will be compared between baseline, post-op, and 1 year follow up |
| 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 |
| Change in PR interval | 1 year post-surgery | PR interval will be compared between baseline, post-op, and 1 year follow up |
| Residual lesion score (RLS) at discharge | Surgery to discharge (approximately 5 days) | RLS will be compared between groups |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed