Atrial Septal Defect
Conditions
Brief summary
The investigators propose to translate confocal microscopy for use during open heart surgery. This tool will help discriminate between various types of tissues in the heart during surgery. One of the most feared complication after heart surgery is heart block. This flexible fiberoptic confocal microscope will help discriminate between the various types of tissues in the heart and thus help avoid injury to the conduction tissue during surgery.
Detailed description
This is an interventional pilot study that proposes to evaluate the safety, logistical feasibility, and technological feasibility of using Fluorescite with fiberoptic confocal microscopy during cardiac surgery to discriminate between cardiac tissue and conduction tissue. During surgery to repair atrial septal defect, diluted Fluorescite will be added to the surface of the heart. The fiberoptic confocal microscope (Cellvizio 100 Series System with Confocal Miniprobe) will be used to record images in several different locations of the heart. The image files will be provided to blinded raters who will attempt to identify whether they contain cardiac tissue or conduction tissue. All subjects will be monitored while they are inpatient after surgery for any adverse events.
Interventions
DRUGFluorescite
Dilute fluorescite will be applied to cardiac tissue prior to imaging
Microscopy system will image cardiac tissue.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Aditya Kaza
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Days to 21 Years
Healthy volunteers
No
Inclusion criteria
* Males and females between 30 days and 21 years old * Undergoing elective surgery for closure of atrial septal defect * Both parents attend pre-operative clinic appointment, to provide 2 parent consent, or an adult participant (age 18-21) may provide consent for him/herself
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 \> 87% for age * Underlying genetic syndrome associated with progressive AV block of sinus node dysfunction (e.g. Holt-Oram or NKX2.5)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Adverse Events Possibly Related to Study Intervention | Surgery through discharge (approximately 5 days) | All adverse events will be collected and relatedness to study intervention will be determined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants For Whom FCM Imaging During Cardiac Surgery Was Feasible | Surgery through discharge (approximately 5 days) | Evaluated by measuring increased time on bypass, rate of enrollment, and the ability to incorporate this imaging modality into standard OR procedures. The additional time on bypass and ability to incorporate the imaging into standard OR procedures was assessed for each subject. 3 additional minutes on bypass was determined as reasonable per the protocol. The ability to incorporate the imaging was considered successful when it did not interfere with the planned clinical procedure. The rate of enrollment was evaluated for the study as a whole. |
| Percentage of Agreement in Classification of FCM Images | After all participants completed the study (range 2 months to 1 year post surgery) | A first reviewer selected 60 FCM images and classified them as reticulated, striated, or of poor quality (indistinguishable microstructure) with 20 images in each group. Quality of the files is measured by the ability of 8 blinded reviewers to classify the images accurately. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Imaging Arm 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
Fluorescite: Dilute fluorescite will be applied to cardiac tissue prior to imaging
Cellvizio 100 Series System with Confocal Miniprobes: Microscopy system will image cardiac tissue. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Imaging Arm |
|---|---|
| Age, Categorical <=18 years | 6 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 6 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Number of Participants Who Experienced Adverse Events Possibly Related to Study Intervention
All adverse events will be collected and relatedness to study intervention will be determined.
Time frame: Surgery through discharge (approximately 5 days)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imaging Arm | Number of Participants Who Experienced Adverse Events Possibly Related to Study Intervention | Experienced AE related to study intervention | 0 Participants |
| Imaging Arm | Number of Participants Who Experienced Adverse Events Possibly Related to Study Intervention | Experienced AE unrelated to study intervention | 6 Participants |
Secondary
Number of Participants For Whom FCM Imaging During Cardiac Surgery Was Feasible
Evaluated by measuring increased time on bypass, rate of enrollment, and the ability to incorporate this imaging modality into standard OR procedures. The additional time on bypass and ability to incorporate the imaging into standard OR procedures was assessed for each subject. 3 additional minutes on bypass was determined as reasonable per the protocol. The ability to incorporate the imaging was considered successful when it did not interfere with the planned clinical procedure. The rate of enrollment was evaluated for the study as a whole.
Time frame: Surgery through discharge (approximately 5 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Imaging Arm | Number of Participants For Whom FCM Imaging During Cardiac Surgery Was Feasible | 6 Participants |
Secondary
Percentage of Agreement in Classification of FCM Images
A first reviewer selected 60 FCM images and classified them as reticulated, striated, or of poor quality (indistinguishable microstructure) with 20 images in each group. Quality of the files is measured by the ability of 8 blinded reviewers to classify the images accurately.
Time frame: After all participants completed the study (range 2 months to 1 year post surgery)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Imaging Arm | Percentage of Agreement in Classification of FCM Images | 90.4 % of agreement with unblinded reviewer |