Utilization of Confocal Microscopy During Cardiac Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-02

Study Completion Date

2019-04-26

Brief Summary

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The investigators propose to translate confocal microscopy for use during open heart surgery. This tool will help discriminate between various types of tissues in the heart during surgery. One of the most feared complication after heart surgery is heart block. This flexible fiberoptic confocal microscope will help discriminate between the various types of tissues in the heart and thus help avoid injury to the conduction tissue during surgery.

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Detailed Description

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This is an interventional pilot study that proposes to evaluate the safety, logistical feasibility, and technological feasibility of using Fluorescite with fiberoptic confocal microscopy during cardiac surgery to discriminate between cardiac tissue and conduction tissue. During surgery to repair atrial septal defect, diluted Fluorescite will be added to the surface of the heart. The fiberoptic confocal microscope (Cellvizio 100 Series System with Confocal Miniprobe) will be used to record images in several different locations of the heart. The image files will be provided to blinded raters who will attempt to identify whether they contain cardiac tissue or conduction tissue. All subjects will be monitored while they are inpatient after surgery for any adverse events.

Conditions

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Atrial Septal Defect

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Imaging arm

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

Group Type EXPERIMENTAL

Fluorescite

Intervention Type DRUG

Dilute fluorescite will be applied to cardiac tissue prior to imaging

Cellvizio 100 Series System with Confocal Miniprobes

Intervention Type DEVICE

Microscopy system will image cardiac tissue.

Interventions

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Fluorescite

Dilute fluorescite will be applied to cardiac tissue prior to imaging

Intervention Type DRUG

Cellvizio 100 Series System with Confocal Miniprobes

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

* Males and females between 30 days and 21 years old
* Undergoing elective surgery for closure of atrial septal defect
* Both parents attend pre-operative clinic appointment, to provide 2 parent consent, or an adult participant (age 18-21) may provide consent for him/herself

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 \> 87% for age
* Underlying genetic syndrome associated with progressive AV block of sinus node dysfunction (e.g. Holt-Oram or NKX2.5)

Minimum Eligible Age

30 Days

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No