Phase 1 N=6 Basic Science

Utilization of Confocal Microscopy During Cardiac Surgery

Atrial Septal Defect

Bottom Line

View on ClinicalTrials.gov: NCT03189134 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2020

Primary outcome: Primary: Number of Participants Who Experienced Adverse Events Possibly Related to Study Intervention — 0; 6 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Fluorescite (Drug); Cellvizio 100 Series System with Confocal Miniprobes (Device)
Age: Pediatric, Adult · 0+ yrs
Sex: All
Sponsor: Aditya Kaza
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Experienced Adverse Events Possibly Related to Study Intervention	0; 6	—
SECONDARY Number of Participants For Whom FCM Imaging During Cardiac Surgery Was Feasible	6	—
SECONDARY Percentage of Agreement in Classification of FCM Images	90.4	—

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 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03189134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.