Utilization of Confocal Microscopy During Cardiac Surgery

Aditya Kaza

Status and phase: Completed; Phase 1

Conditions: Atrial Septal Defect

Treatments: Drug: Fluorescite; Device: Cellvizio 100 Series System with Confocal Miniprobes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03189134

R56HL128813 (U.S. NIH Grant/Contract)

P00013570

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 6 patients

Sex: All

Ages: 30 days to 21 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Imaging arm

Experimental group

Description:

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

Treatment:

Drug: Fluorescite

Device: Cellvizio 100 Series System with Confocal Miniprobes