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Trial record 5 of 12 for:    Atrial Septal Defect 5

Utilization of Confocal Microscopy During Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03189134
Recruitment Status : Completed
First Posted : June 16, 2017
Last Update Posted : May 22, 2019
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Aditya Kaza, Boston Children’s Hospital

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.

Condition or disease Intervention/treatment Phase
Atrial Septal Defect Drug: Fluorescite Device: Cellvizio 100 Series System with Confocal Miniprobes Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Utilization of Confocal Microscopy During Cardiac Surgery
Actual Study Start Date : April 2, 2018
Actual Primary Completion Date : March 4, 2019
Actual Study Completion Date : April 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: Imaging arm
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
Drug: Fluorescite
Dilute fluorescite will be applied to cardiac tissue prior to imaging
Other Name: fluorescein sodium

Device: Cellvizio 100 Series System with Confocal Miniprobes
Microscopy system will image cardiac tissue.

Primary Outcome Measures :
  1. Adverse events and rates of post-surgical complications [ Time Frame: Surgery through discharge (approximately 5 days) ]
    All adverse events will be collected and relatedness to study participation will be determined. Complications will be compared to average complication rates for ASD repairs.

Secondary Outcome Measures :
  1. The logistical feasibility of conducting FCM imaging during cardiac surgery [ Time Frame: Surgery through discharge (approximately 5 days) ]
    Evaluated by measuring increased time on bypass, rate of enrollment, and the ability to incorporate this imaging modality into standard OR procedures. All of the factors will be combined to determine feasibility.

  2. Quality of the FCM image files collected [ Time Frame: End of study (approximately 6 months) ]
    Quality will be defined as the ability of observers to distinguish features and discriminate between working myocardium and nodal tissue.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03189134

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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Aditya Kaza
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Aditya K Kaza Boston Children’s Hospital

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Responsible Party: Aditya Kaza, Associate in Cardiac Surgery, Boston Children’s Hospital Identifier: NCT03189134     History of Changes
Other Study ID Numbers: P00013570
R56HL128813 ( U.S. NIH Grant/Contract )
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Additional relevant MeSH terms:
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Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities