Optical Tissue Identification for Myocardial Architecture

• Register: ClinicalTrials.gov
• Last refreshed on: 26 June 2023
• Main ID: NCT04017975
• Date of registration: 10/07/2019
• Prospective Registration: Yes
• Primary sponsor: Aditya Kaza
• Public title: Optical Tissue Identification for Myocardial Architecture OPTIMA
• Scientific title: Optical Tissue Identification for Myocardial Architecture (OPTIMA Study)
• Date of first enrolment: December 20, 2019
• Target sample size: 70
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT04017975
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Aditya K Kaza, MD
• Affiliation: Boston Children's Hospital

Key inclusion & exclusion 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



Age minimum: 30 Days
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ventricular Septal Defect

Complete Atrioventricular Canal

Tetralogy of Fallot With Pulmonary Stenosis

Intervention(s)

Device: Cellvizio 100 Series System with Confocal Miniprobes

Drug: Fluorescite

Primary Outcome(s)

Rate of new conduction disorders [Time Frame: Immediately post-surgery]

Secondary Outcome(s)

Time to temporary pacing wire removal prior to discharge [Time Frame: Surgery to discharge (approximately 5 days)]

Adverse events [Time Frame: 1 year post-surgery]

Residual lesion score (RLS) at discharge [Time Frame: Surgery to discharge (approximately 5 days)]

Change in QTc interval [Time Frame: 1 year post-surgery]

Degree of heart block [Time Frame: 1 year post-surgery]

Change in PR interval [Time Frame: 1 year post-surgery]

Change in QRS interval [Time Frame: Approximately 5 days post-surgery and 1 year post-surgery]

Need for repeat bypass [Time Frame: 1 day]

Ease of use [Time Frame: 1 day]

Pacemaker implantation [Time Frame: 1 year post-surgery]

Secondary ID(s)

P00031701

R56HL128813

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)