Optical Tissue Identification for Myocardial Architecture

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Brief Title

Optical Tissue Identification for Myocardial Architecture

Official Title

Optical Tissue Identification for Myocardial Architecture (OPTIMA Study)

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Rate of new conduction disorders

Secondary Outcome

 Change in PR interval

Condition

Ventricular Septal Defect

Intervention

Fluorescite

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

70

Start Date

December 20, 2019

Completion Date

November 2022

Primary Completion Date

November 2022

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
      

Gender

All

Ages

N/A - 18 Years

Accepts Healthy Volunteers

No

Contacts

Aditya K Kaza, MD, 617-919-4457, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04017975

Organization ID

P00031701

Secondary IDs

R56HL128813

Responsible Party

Sponsor-Investigator

Study Sponsor

Aditya Kaza

Collaborators

 National Heart, Lung, and Blood Institute (NHLBI)

Study Sponsor

Aditya K Kaza, MD, Principal Investigator, Boston Children's Hospital


Verification Date

June 2021