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Utilization of Confocal Microscopy During Cardiac Surgery

NCT03189134 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-07-07

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Aditya Kaza

    lead OTHER

Principal Investigators

  • Aditya K Kaza · Boston Children's Hospital

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Days
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-02
Primary Completion
2019-03-04
Completion
2019-04-26
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03189134 on ClinicalTrials.gov