Optical Tissue Identification for Myocardial Architecture (OPTIMA)

Aditya Kaza

Status and phase: Active, not recruiting; Phase 2

Conditions: Tetralogy of Fallot With Pulmonary Stenosis; Complete Atrioventricular Canal; Ventricular Septal Defect

Treatments: Drug: Fluorescite; Device: Cellvizio 100 Series System with Confocal Miniprobes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04017975

R56HL128813 (U.S. NIH Grant/Contract)

P00031701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 30 days to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

70 participants in 2 patient groups

Non-imaging cohort

No Intervention group

Description:

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

Imaging cohort

Experimental group

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.

Treatment:

Device: Cellvizio 100 Series System with Confocal Miniprobes

Drug: Fluorescite