NCT03189134

Utilization of Confocal Microscopy During Cardiac Surgery

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Aditya Kaza · Academic / Other
• Sex: All
• Age: 30 Days – 21 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Atrial Septal Defect

Interventions

Type	Name	Description
DRUG	Fluorescite	Dilute fluorescite will be applied to cardiac tissue prior to imaging
DEVICE	Cellvizio 100 Series System with Confocal Miniprobes	Microscopy system will image cardiac tissue.

Timeline

• Start date: 2018-04-02
• Primary completion: 2019-03-04
• Completion: 2019-04-26
• First posted: 2017-06-16
• Last updated: 2020-07-07
• Results posted: 2020-07-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study