Active — Not RecruitingPhase 2

Optical Tissue Identification for Myocardial Architecture

United States70 participantsStarted 2019-12-20

Plain-language 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.

Who can participate

Age range30 Days – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rate of new conduction disorders

Timeframe: Immediately post-surgery

Trial details

NCT IDNCT04017975

SponsorAditya Kaza

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09

View on ClinicalTrials.gov More Ventricular Septal Defect trials