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Optical Tissue Identification for Myocardial Architecture (OPTIMA)

Primary Purpose

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

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluorescite
Cellvizio 100 Series System with Confocal Miniprobes
Sponsored by
Aditya Kaza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventricular Septal Defect focused on measuring fiberoptic confocal microscopy, cardiac surgery

Eligibility Criteria

30 Days - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

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 > 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
  • Exclusions specific to type of surgical repair
  • Apical muscular VSD
  • ToF with pulmonary atresia

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Non-imaging cohort

Imaging cohort

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in PR interval
PR interval will be compared between baseline, post-op, and 1 year follow up
Change in QTc interval
QTc interval will be compared between baseline, post-op, and 1 year follow up
Change in QRS interval
QRS interval will be compared between baseline, post-op, and 1 year follow up
Degree of heart block
Degree of heart block will be assessed at post-op and 1 year follow up
Pacemaker implantation
Incidence of temporary and permanent pacemaker implantation will be collected
Time to temporary pacing wire removal prior to discharge
If a temporary pacing wire is placed, time to removal will be collected
Residual lesion score (RLS) at discharge
RLS will be compared between groups
Need for repeat bypass
Need for repeat bypass for residual lesions during surgery will be collected
Adverse events
Rates of adverse events will be collected and compared between the two group
Ease of use
Surgeon feedback regarding using the FCM system will be collected using a brief survey

Full Information

First Posted
July 10, 2019
Last Updated
June 13, 2023
Sponsor
Aditya Kaza
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT04017975
Brief Title
Optical Tissue Identification for Myocardial Architecture
Acronym
OPTIMA
Official Title
Optical Tissue Identification for Myocardial Architecture (OPTIMA Study)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aditya Kaza
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This is an interventional randomized controlled study to investigate the use of fiberoptic confocal microscopy (FCM) imaging for avoidance of conduction abnormalities during repair of common congenital heart defects. Study results will be compared to a cohort of similar surgical patients following standard surgical procedures where FCM was not used. We will analyze pre-and postoperative ECGs to identify conduction abnormalities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Septal Defect, Complete Atrioventricular Canal, Tetralogy of Fallot With Pulmonary Stenosis
Keywords
fiberoptic confocal microscopy, cardiac surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized into two groups using permuted block and stratified according to type of surgical repair.
Masking
ParticipantOutcomes Assessor
Masking Description
Subjects and the physician reading ECGs will be blinded.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-imaging cohort
Arm Type
No Intervention
Arm Description
There will be no intervention for the non-imaging group. Subjects will receive standard of care for cardiac surgery.
Arm Title
Imaging cohort
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fluorescite
Other Intervention Name(s)
fluorescein sodium
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Cellvizio 100 Series System with Confocal Miniprobes
Intervention Description
The microscopy system will image cardiac tissue.
Primary Outcome Measure Information:
Title
Rate of new conduction disorders
Description
Rate of new conduction disorders post-surgery will be determined by electrophysiologist read and compared between the two groups
Time Frame
Immediately post-surgery
Secondary Outcome Measure Information:
Title
Change in PR interval
Description
PR interval will be compared between baseline, post-op, and 1 year follow up
Time Frame
1 year post-surgery
Title
Change in QTc interval
Description
QTc interval will be compared between baseline, post-op, and 1 year follow up
Time Frame
1 year post-surgery
Title
Change in QRS interval
Description
QRS interval will be compared between baseline, post-op, and 1 year follow up
Time Frame
Approximately 5 days post-surgery and 1 year post-surgery
Title
Degree of heart block
Description
Degree of heart block will be assessed at post-op and 1 year follow up
Time Frame
1 year post-surgery
Title
Pacemaker implantation
Description
Incidence of temporary and permanent pacemaker implantation will be collected
Time Frame
1 year post-surgery
Title
Time to temporary pacing wire removal prior to discharge
Description
If a temporary pacing wire is placed, time to removal will be collected
Time Frame
Surgery to discharge (approximately 5 days)
Title
Residual lesion score (RLS) at discharge
Description
RLS will be compared between groups
Time Frame
Surgery to discharge (approximately 5 days)
Title
Need for repeat bypass
Description
Need for repeat bypass for residual lesions during surgery will be collected
Time Frame
1 day
Title
Adverse events
Description
Rates of adverse events will be collected and compared between the two group
Time Frame
1 year post-surgery
Title
Ease of use
Description
Surgeon feedback regarding using the FCM system will be collected using a brief survey
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 > 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 Exclusions specific to type of surgical repair Apical muscular VSD ToF with pulmonary atresia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aditya K Kaza, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data to other researchers.

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Optical Tissue Identification for Myocardial Architecture

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