Utilization of Confocal Microscopy During Cardiac Surgery



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 17
Updated:3/6/2019
Start Date:April 2, 2018
End Date:August 2019
Contact:Ashley E Kuniholm
Email:ashley.kuniholm@childrens.harvard.edu
Phone:617-355-6513

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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.

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.

Inclusion Criteria:

- Males and females between 30 days and 17 years old

- Undergoing elective surgery for closure of atrial septal defect

- Both parents attend pre-operative clinic appointment, to provide 2 parent consent

Exclusion Criteria:

- Prior history of adverse reaction to fluorescein sodium

- Abnormal renal function defined as creatinine level > 1.5mg/dL
We found this trial at
1
site
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Aditya K Kaza, MD
Phone: 617-355-6513
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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mi
from
Boston, MA
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