Optical Tissue Identification for Myocardial Architecture

NCT04017975 | Unknown Phase 2 DMC FDA Drug FDA Device

• 2 other identifiers: P00031701R56HL128813
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to test the hypothesis that fiberoptic confocal microscopy (FCM) imaging during repair of common congenital heart defects is a useful adjunct for avoidance of conduction abnormalities.

Conditions

Ventricular Septal Defect; Complete Atrioventricular Canal; Tetralogy of Fallot With Pulmonary Stenosis

Keywords

fiberoptic confocal microscopy; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Rate of new conduction disorders

  Rate of new conduction disorders post-surgery will be determined by electrophysiologist read and compared between the two groups

  Immediately post-surgery

Secondary Outcomes (10)

• Change in PR interval

  1 year post-surgery

• Change in QTc interval

  1 year post-surgery

• Change in QRS interval

  Approximately 5 days post-surgery and 1 year post-surgery

• Degree of heart block

  1 year post-surgery

• Pacemaker implantation

  1 year post-surgery

Study Arms (2)

Non-imaging cohort

NO INTERVENTION

There will be no intervention for the non-imaging group. Subjects will receive standard of care for cardiac surgery.

Imaging cohort

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. The system will be used to assist the investigator with the operative course.

Drug: Fluorescite; Device: Cellvizio 100 Series System with Confocal Miniprobes

Interventions

Fluorescite DRUG

1 mL of Fluorescite will be diluted into 1L of saline. Up to 5mLs of the 1:1000 diluted solution will be applied topically to the cardiac tissue prior to imaging.

Also known as: fluorescein sodium

Imaging cohort

Cellvizio 100 Series System with Confocal Miniprobes DEVICE

The microscopy system will image cardiac tissue.

Imaging cohort

Eligibility Criteria

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

You may qualify if:

• Age 30 days to less than 18 years old
• Patients with planned surgical repair of:
• Ventricular septal defect (VSD)
• Complete atrioventricular canal (CAVC)
• Tetralogy of Fallot (ToF) with pulmonary stenosis

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 \> 98% for age
• Underlying genetic syndrome associated with progressive AV block or sinus node dysfunction (e.g. Holt-Oram or NKX2.5)
• Any surgical repair that requires staging or palliation
• Pregnant or lactating
• Apical muscular VSD
• ToF with pulmonary atresia

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

MeSH Terms

Conditions

Heart Septal Defects, Ventricular; Complete atrioventricular septal defect

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

Study Officials

• Aditya K Kaza, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects and the physician reading ECGs will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate in Cardiac Surgery

Model Details: Subjects will be randomized into two groups using permuted block and stratified according to type of surgical repair.

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 12, 2019
• Study Start: December 20, 2019
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)