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Completed

NCT Number: NCT03189134

Utilization of Confocal Microscopy During Cardiac Surgery

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.

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Key information

Conditions

Atrial Septal Defect Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial

Age range

30 day–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fluorescite

Drug

Dilute fluorescite will be applied to cardiac tissue prior to imaging

Other names: fluorescein sodium

Cellvizio 100 Series System with Confocal Miniprobes

Device

Microscopy system will image cardiac tissue.

Primary outcomes

  1. Number of Participants Who Experienced Adverse Events Possibly Related to Study Intervention

    Time frame: Surgery through discharge (approximately 5 days)

    All adverse events will be collected and relatedness to study intervention will be determined.

Secondary outcomes

  1. Number of Participants For Whom FCM Imaging During Cardiac Surgery Was Feasible

    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. 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.

  2. Percentage of Agreement in Classification of FCM Images

    Time frame: After all participants completed the study (range 2 months to 1 year post surgery)

    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.

Sponsors and collaborators

Lead sponsor

Aditya Kaza

Other

Collaborators

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

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 16, 2017
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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