Clinical trial NCT03189134: Utilization of Confocal Microscopy During Cardiac Surgery
Official title: Utilization of Confocal Microscopy During Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atrial Septal Defect
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-06-16
Enrollment: 6
Sex: ALL
Minimum age (years): 30
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Number of Participants Who Experienced Adverse Events Possibly Related to Study Intervention
timeFrame: Surgery through discharge (approximately 5 days)
Secondary outcomes:
measure: Number of Participants For Whom FCM Imaging During Cardiac Surgery Was Feasible
timeFrame: Surgery through discharge (approximately 5 days)
measure: Percentage of Agreement in Classification of FCM Images
timeFrame: After all participants completed the study (range 2 months to 1 year post surgery)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Aditya K Kaza
role: PRINCIPAL_INVESTIGATOR
References:
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.