Utilization of Confocal Microscopy During Cardiac Surgery

Atrial Septal Defect Clinical Trial

Official title:

Utilization of Confocal Microscopy During Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03189134
• Other study ID #: P00013570
• Secondary ID: R56HL128813
• Status: Completed
• Phase: Phase 1
• Start date: April 2, 2018
• Est. completion date: April 26, 2019

Study information

• Verified date: July 2020
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 26, 2019
• Est. primary completion date: March 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Septal Defect
• Heart Septal Defects, Atrial

Intervention

Drug:
• Fluorescite
Dilute fluorescite will be applied to cardiac tissue prior to imaging

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

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Aditya Kaza	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Surgery through discharge (approximately 5 days)
Secondary	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.	Surgery through discharge (approximately 5 days)
Secondary	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.	After all participants completed the study (range 2 months to 1 year post surgery)