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Optical Tissue Identification for Myocardial Architecture (OPTIMA)

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ClinicalTrials.gov Identifier: NCT04017975
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : November 19, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Aditya Kaza, Boston Children’s Hospital

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.

Condition or disease Intervention/treatment Phase
Ventricular Septal Defect Complete Atrioventricular Canal Tetralogy of Fallot With Pulmonary Stenosis Drug: Fluorescite Device: Cellvizio 100 Series System with Confocal Miniprobes Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized into two groups using permuted block and stratified according to type of surgical repair.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Subjects and the physician reading ECGs will be blinded.
Primary Purpose: Prevention
Official Title: Optical Tissue Identification for Myocardial Architecture (OPTIMA Study)
Estimated Study Start Date : November 15, 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022


Arm Intervention/treatment
No Intervention: Non-imaging cohort
There will be no intervention for the non-imaging group. Subjects will receive standard of care for cardiac surgery.
Experimental: Imaging cohort
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
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.
Other Name: fluorescein sodium

Device: Cellvizio 100 Series System with Confocal Miniprobes
The microscopy system will image cardiac tissue.




Primary Outcome Measures :
  1. Rate of new conduction disorders [ Time Frame: Immediately post-surgery ]
    Rate of new conduction disorders post-surgery will be determined by electrophysiologist read and compared between the two groups


Secondary Outcome Measures :
  1. Change in PR interval [ Time Frame: 1 year post-surgery ]
    PR interval will be compared between baseline, post-op, and 1 year follow up

  2. Change in QTc interval [ Time Frame: 1 year post-surgery ]
    QTc interval will be compared between baseline, post-op, and 1 year follow up

  3. Change in QRS interval [ Time Frame: Approximately 5 days post-surgery and 1 year post-surgery ]
    QRS interval will be compared between baseline, post-op, and 1 year follow up

  4. Degree of heart block [ Time Frame: 1 year post-surgery ]
    Degree of heart block will be assessed at post-op and 1 year follow up

  5. Pacemaker implantation [ Time Frame: 1 year post-surgery ]
    Incidence of temporary and permanent pacemaker implantation will be collected

  6. Time to temporary pacing wire removal prior to discharge [ Time Frame: Surgery to discharge (approximately 5 days) ]
    If a temporary pacing wire is placed, time to removal will be collected

  7. Residual lesion score (RLS) at discharge [ Time Frame: Surgery to discharge (approximately 5 days) ]
    RLS will be compared between groups

  8. Need for repeat bypass [ Time Frame: 1 day ]
    Need for repeat bypass for residual lesions during surgery will be collected

  9. Adverse events [ Time Frame: 1 year post-surgery ]
    Rates of adverse events will be collected and compared between the two group

  10. Ease of use [ Time Frame: 1 day ]
    Surgeon feedback regarding using the FCM system will be collected using a brief survey



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017975


Contacts
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Contact: Leah Cheng 857-218-4731 leah.cheng@childrens.harvard.edu
Contact: Caroline Rogalski 857-218-5299 caroline.rogalski@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Leah Cheng    857-218-4731    leah.cheng@childrens.harvard.edu   
Principal Investigator: Aditya K Kaza, MD         
Sponsors and Collaborators
Aditya Kaza
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Aditya K Kaza, MD Boston Children’s Hospital

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Responsible Party: Aditya Kaza, Associate in Cardiac Surgery, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT04017975     History of Changes
Other Study ID Numbers: P00031701
R56HL128813 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data to other researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Aditya Kaza, Boston Children’s Hospital:
fiberoptic confocal microscopy
cardiac surgery
Additional relevant MeSH terms:
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Heart Septal Defects, Ventricular
Heart Septal Defects
Heart Defects, Congenital
Heart Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction
Tetralogy of Fallot
Pulmonary Valve Stenosis
Endocardial Cushion Defects
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities