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Optical Tissue Identification for Myocardial Architecture

NCT04017975 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-06-15

No results posted yet for this study

Summary

The goal of this study is to test the hypothesis that fiberoptic confocal microscopy (FCM) imaging during repair of common congenital heart defects is a useful adjunct for avoidance of conduction abnormalities.

Conditions

  • Ventricular Septal Defect
  • Complete Atrioventricular Canal
  • Tetralogy of Fallot With Pulmonary Stenosis

Interventions

DRUG

Fluorescite

1 mL of Fluorescite will be diluted into 1L of saline. Up to 5mLs of the 1:1000 diluted solution will be applied topically to the cardiac tissue prior to imaging.

DEVICE

Cellvizio 100 Series System with Confocal Miniprobes

The 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, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-12-20
Primary Completion
2023-09-30
Completion
2023-09-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04017975 on ClinicalTrials.gov