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Utilization of Confocal Microscopy During Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT03189134
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : March 4, 2019
Sponsor:
Collaborator:
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)
Estimated 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
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : August 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.



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females between 30 days and 17 years old
  • Undergoing elective surgery for closure of atrial septal defect
  • Both parents attend pre-operative clinic appointment, to provide 2 parent consent

Exclusion Criteria:

  • Prior history of adverse reaction to fluorescein sodium
  • Abnormal renal function defined as creatinine level > 1.5mg/dL

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 ClinicalTrials.gov identifier (NCT number): NCT03189134


Contacts
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Contact: Ashley E Kuniholm 617-355-6513 ashley.kuniholm@childrens.harvard.edu
Contact: Leah Cheng 857-218-4731 leah.cheng@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Ashley Kuniholm    617-355-6513    ashley.kuniholm@childrens.harvard.edu   
Contact: Leah Cheng    857-218-4731    leah.cheng@childrens.harvard.edu   
Principal Investigator: Aditya K Kaza, MD         
Sponsors and Collaborators
Aditya Kaza
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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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
ClinicalTrials.gov 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: March 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities