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.
Conditions
Atrial Septal Defect
Recruitment Status
Completed
Detailed 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.
Eligibility Criteria
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)
Intervention
Intervention Type
Intervention Name
Drug
Fluorescite
Device
Cellvizio 100 Series System with Confocal Miniprobes
Phase
Phase 1
Gender
All
Min Age
30 Days
Max Age
21 Years
Download Date
July 7, 2020
Principal Investigator
Aditya Kaza
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: