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Utilization of Confocal Microscopy During Cardiac Surgery

Primary Purpose

Atrial Septal Defect

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fluorescite
Cellvizio 100 Series System with Confocal Miniprobes
Sponsored by
Aditya Kaza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atrial Septal Defect

Eligibility Criteria

30 Days - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imaging arm

Arm Description

Up to 5mL of 1:1000 dilute FLUORESCITE will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes

Outcomes

Primary Outcome Measures

Number of Participants Who Experienced Adverse Events Possibly Related to Study Intervention
All adverse events will be collected and relatedness to study intervention will be determined.

Secondary Outcome Measures

Number of Participants For Whom FCM Imaging During Cardiac Surgery Was Feasible
Evaluated by measuring increased time on bypass, rate of enrollment, and the ability to incorporate this imaging modality into standard OR procedures. The additional time on bypass and ability to incorporate the imaging into standard OR procedures was assessed for each subject. 3 additional minutes on bypass was determined as reasonable per the protocol. The ability to incorporate the imaging was considered successful when it did not interfere with the planned clinical procedure. The rate of enrollment was evaluated for the study as a whole.
Percentage of Agreement in Classification of FCM Images
A first reviewer selected 60 FCM images and classified them as reticulated, striated, or of poor quality (indistinguishable microstructure) with 20 images in each group. Quality of the files is measured by the ability of 8 blinded reviewers to classify the images accurately.

Full Information

First Posted
May 22, 2017
Last Updated
July 3, 2020
Sponsor
Aditya Kaza
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03189134
Brief Title
Utilization of Confocal Microscopy During Cardiac Surgery
Official Title
Utilization of Confocal Microscopy During Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
March 4, 2019 (Actual)
Study Completion Date
April 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aditya Kaza
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Septal Defect

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imaging arm
Arm Type
Experimental
Arm Description
Up to 5mL of 1:1000 dilute FLUORESCITE will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes
Intervention Type
Drug
Intervention Name(s)
Fluorescite
Other Intervention Name(s)
fluorescein sodium
Intervention Description
Dilute fluorescite will be applied to cardiac tissue prior to imaging
Intervention Type
Device
Intervention Name(s)
Cellvizio 100 Series System with Confocal Miniprobes
Intervention Description
Microscopy system will image cardiac tissue.
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced Adverse Events Possibly Related to Study Intervention
Description
All adverse events will be collected and relatedness to study intervention will be determined.
Time Frame
Surgery through discharge (approximately 5 days)
Secondary Outcome Measure Information:
Title
Number of Participants For Whom FCM Imaging During Cardiac Surgery Was Feasible
Description
Evaluated by measuring increased time on bypass, rate of enrollment, and the ability to incorporate this imaging modality into standard OR procedures. The additional time on bypass and ability to incorporate the imaging into standard OR procedures was assessed for each subject. 3 additional minutes on bypass was determined as reasonable per the protocol. The ability to incorporate the imaging was considered successful when it did not interfere with the planned clinical procedure. The rate of enrollment was evaluated for the study as a whole.
Time Frame
Surgery through discharge (approximately 5 days)
Title
Percentage of Agreement in Classification of FCM Images
Description
A first reviewer selected 60 FCM images and classified them as reticulated, striated, or of poor quality (indistinguishable microstructure) with 20 images in each group. Quality of the files is measured by the ability of 8 blinded reviewers to classify the images accurately.
Time Frame
After all participants completed the study (range 2 months to 1 year post surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aditya K Kaza
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers.
Citations:
PubMed Identifier
32083653
Citation
Kaza AK, Mondal A, Piekarski B, Sachse FB, Hitchcock R. Intraoperative localization of cardiac conduction tissue regions using real-time fibre-optic confocal microscopy: first in human trial. Eur J Cardiothorac Surg. 2020 Aug 1;58(2):261-268. doi: 10.1093/ejcts/ezaa040.
Results Reference
derived

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Utilization of Confocal Microscopy During Cardiac Surgery

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