Trials / Active Not Recruiting
Active Not RecruitingNCT04017975
Optical Tissue Identification for Myocardial Architecture
Optical Tissue Identification for Myocardial Architecture (OPTIMA Study)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Aditya Kaza · Academic / Other
- Sex
- All
- Age
- 30 Days – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fluorescite | 1 mL of Fluorescite will be diluted into 1L of saline. Up to 5mLs of the 1:1000 diluted solution will be applied topically to the cardiac tissue prior to imaging. |
| DEVICE | Cellvizio 100 Series System with Confocal Miniprobes | The microscopy system will image cardiac tissue. |
Timeline
- Start date
- 2019-12-20
- Primary completion
- 2023-09-01
- Completion
- 2023-09-01
- First posted
- 2019-07-12
- Last updated
- 2023-06-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04017975. Inclusion in this directory is not an endorsement.