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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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