Clinical trial NCT04017975: Optical Tissue Identification for Myocardial Architecture
Official title: Optical Tissue Identification for Myocardial Architecture (OPTIMA Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ventricular Septal Defect
Complete Atrioventricular Canal
Tetralogy of Fallot With Pulmonary Stenosis
Keywords: fiberoptic confocal microscopy
cardiac surgery
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-07-12
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized into two groups using permuted block and stratified according to type of surgical repair.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of new conduction disorders
timeFrame: Immediately post-surgery
Secondary outcomes:
measure: Change in PR interval
timeFrame: 1 year post-surgery
measure: Change in QTc interval
timeFrame: 1 year post-surgery
measure: Change in QRS interval
timeFrame: Approximately 5 days post-surgery and 1 year post-surgery
measure: Degree of heart block
timeFrame: 1 year post-surgery
measure: Pacemaker implantation
timeFrame: 1 year post-surgery
measure: Time to temporary pacing wire removal prior to discharge
timeFrame: Surgery to discharge (approximately 5 days)
measure: Residual lesion score (RLS) at discharge
timeFrame: Surgery to discharge (approximately 5 days)
measure: Need for repeat bypass
timeFrame: 1 day
measure: Adverse events
timeFrame: 1 year post-surgery
measure: Ease of use
timeFrame: 1 day
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Aditya K Kaza, MD
role: PRINCIPAL_INVESTIGATOR
References: