Optical Tissue Identification for Myocardial Architecture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-20

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ventricular Septal Defect Complete Atrioventricular Canal Tetralogy of Fallot With Pulmonary Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized into two groups using permuted block and stratified according to type of surgical repair.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Subjects and the physician reading ECGs will be blinded.

Study Groups

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Non-imaging cohort

There will be no intervention for the non-imaging group. Subjects will receive standard of care for cardiac surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Fluorescite

Intervention Type 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.

Cellvizio 100 Series System with Confocal Miniprobes

Intervention Type DEVICE

The microscopy system will image cardiac tissue.

Interventions

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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.

Intervention Type DRUG

Cellvizio 100 Series System with Confocal Miniprobes

The microscopy system will image cardiac tissue.

Intervention Type DEVICE

Other Intervention Names

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fluorescein sodium

Eligibility Criteria

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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

Minimum Eligible Age

30 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No