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 range

30 Days – 18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

30 Days – 18 Years

Sex

ALL

See this in plain English?

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