Utilization of Confocal Microscopy During Cardiac Surgery

NCT03189134 | Completed Phase 1 Results DMC FDA Drug FDA Device

• 2 other identifiers: P00013570R56HL128813
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Septal Defect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Surgery through discharge (approximately 5 days)

• Percentage of Agreement in Classification of FCM Images

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

Study Arms (1)

Imaging arm

EXPERIMENTAL

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; Device: Cellvizio 100 Series System with Confocal Miniprobes

Interventions

Fluorescite DRUG

Dilute fluorescite will be applied to cardiac tissue prior to imaging

Also known as: fluorescein sodium

Imaging arm

Cellvizio 100 Series System with Confocal Miniprobes DEVICE

Microscopy system will image cardiac tissue.

Imaging arm

Eligibility Criteria

• Age: 30 Days - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aditya Kaza: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 32083653 DERIVED

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Interventions

Fluorescein

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Aditya K. Kaza, MD
• Organization: Boston Children's Hospital

aditya.kaza@cardio.chboston.org

617-355-7932

Study Officials

• Aditya K Kaza

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate in Cardiac Surgery

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: June 16, 2017
• Study Start: April 2, 2018
• Primary Completion: March 4, 2019
• Study Completion: April 26, 2019
• Last Updated: July 7, 2020
• Results First Posted: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)