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| ID | Type | Description | Link |
|---|---|---|---|
| R56HL128813 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-imaging cohort | No Intervention | There will be no intervention for the non-imaging group. Subjects will receive standard of care for cardiac surgery. | |
| Imaging cohort | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorescite | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of new conduction disorders | Rate of new conduction disorders post-surgery will be determined by electrophysiologist read and compared between the two groups | Immediately post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PR interval | PR interval will be compared between baseline, post-op, and 1 year follow up | 1 year post-surgery |
| Change in QTc interval | QTc interval will be compared between baseline, post-op, and 1 year follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aditya K Kaza, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
There is no plan to share individual participant data to other researchers.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 30, 2026 | Apr 16, 2026 | 7 |
| ID | Term |
|---|---|
| D006345 | Heart Septal Defects, Ventricular |
| C535974 | Complete atrioventricular septal defect |
| ID | Term |
|---|---|
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019793 | Fluorescein |
| ID | Term |
|---|---|
| D005452 | Fluoresceins |
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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Subjects will be randomized into two groups using permuted block and stratified according to type of surgical repair.
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Subjects and the physician reading ECGs will be blinded.
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| Cellvizio 100 Series System with Confocal Miniprobes | Device | The microscopy system will image cardiac tissue. |
|
| 1 year post-surgery |
| Change in QRS interval | QRS interval will be compared between baseline, post-op, and 1 year follow up | Approximately 5 days post-surgery and 1 year post-surgery |
| Degree of heart block | Degree of heart block will be assessed at post-op and 1 year follow up | 1 year post-surgery |
| Pacemaker implantation | Incidence of temporary and permanent pacemaker implantation will be collected | 1 year post-surgery |
| Time to temporary pacing wire removal prior to discharge | If a temporary pacing wire is placed, time to removal will be collected | Surgery to discharge (approximately 5 days) |
| Residual lesion score (RLS) at discharge | RLS will be compared between groups | Surgery to discharge (approximately 5 days) |
| Need for repeat bypass | Need for repeat bypass for residual lesions during surgery will be collected | 1 day |
| Adverse events | Rates of adverse events will be collected and compared between the two group | 1 year post-surgery |
| Ease of use | Surgeon feedback regarding using the FCM system will be collected using a brief survey | 1 day |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009930 |
| Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |