Utilization of Confocal Microscopy During Cardiac Surgery

Last updated: July 3, 2020
Sponsor: Aditya Kaza
Overall Status: Completed

Phase

1

Condition

Pentalogy Of Cantrell

Heart Defect

Treatment

N/A

Clinical Study ID

NCT03189134
P00013570
R56HL128813
  • Ages < 21
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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, oran adult participant (age 18-21) may provide consent for him/herself

Exclusion

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 nodedysfunction (e.g. Holt-Oram or NKX2.5)

Study Design

Total Participants: 6
Study Start date:
April 02, 2018
Estimated Completion Date:
April 26, 2019

Study 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.

Connect with a study center

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

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