Atrial Septal DefectPhase 1NCT03189134
Utilization of Confocal Microscopy During Cardiac Surgery
A Phase 1 study testing Fluorescite and Cellvizio 100 Series System with Confocal Miniprobes in people with Atrial Septal Defect, run by Aditya Kaza at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 days to 21 years
- Conditions the study is for
- Atrial Septal Defect
- What is being tested?
- Fluorescite and Cellvizio 100 Series System with Confocal Miniprobes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2018to 26 Apr 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 days to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Atrial Septal Defect
- Being tested
- Fluorescite, Cellvizio 100 Series System with Confocal Miniprobes
- Medical subject headings
- Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoresciteDrug
Also called fluorescein sodium
Dilute fluorescite will be applied to cardiac tissue prior to imaging
Cellvizio 100 Series System with Confocal MiniprobesDevice
Microscopy system will image cardiac tissue.
| Study group | Role | What they receive |
|---|---|---|
| Imaging arm | 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 Receives: Drug: Fluorescite; Device: Cellvizio 100 Series System with Confocal Miniprobes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Surgery through discharge (approximately 5 days)
Secondary outcomes (2)
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.
Measured: Surgery through discharge (approximately 5 days)
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.
Measured: After all participants completed the study (range 2 months to 1 year post surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start2 Apr 2018
- Primary completion4 Mar 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Septal DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aditya Kaza
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Aditya Kaza, Boston Children's Hospital
- Investigators
- Aditya K Kaza, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189134
- Sponsor's protocol ID
- P00013570
- Other IDs
- R56HL128813
- Status last verified
- Jul 2020
- First submitted
- 22 May 2017
- Last updated
- 7 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
Kaza AK, Mondal A, Piekarski B, Sachse FB, Hitchcock R. Intraoperative localization of cardiac conduction tissue regions using real-time fibre-optic confocal microscopy: first in human trial. Eur J Cardiothorac Surg. 2020 Aug 1;58(2):261-268. doi: 10.1093/ejcts/ezaa040.
PubMed 32083653
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Confocal Microscopy During Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03189134
- Acronym / sponsor ID
- P00013570
- Conditions
- Atrial Septal Defect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Aditya KazaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 4 Mar 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging arm | Experimental | Drug: Fluorescite, Device: Cellvizio 100 Series System with Confocal MiniprobesUp to 5mL of 1:1000 dilute FLUORESCITE will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes |
Who may qualify
- Ages
- 30 days to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluoresciteAlso: fluorescein sodiumDilute fluorescite will be applied to cardiac tissue prior to imaging | Drug | Imaging arm |
| Cellvizio 100 Series System with Confocal MiniprobesMicroscopy system will image cardiac tissue. | Device | Imaging arm |
Primary outcome
Number of Participants Who Experienced Adverse Events Possibly Related to Study Intervention
Time frame: Surgery through discharge (approximately 5 days)
All adverse events will be collected and relatedness to study intervention will be determined.
2 secondary outcomes
Number of Participants For Whom FCM Imaging During Cardiac Surgery Was Feasible
Time frame: Surgery through discharge (approximately 5 days)
Percentage of Agreement in Classification of FCM Images
Time frame: After all participants completed the study (range 2 months to 1 year post surgery)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32083653Kaza AK, Mondal A, Piekarski B, Sachse FB, Hitchcock R. Intraoperative localization of cardiac conduction tissue regions using real-time fibre-optic confocal microscopy: first in human trial. Eur J Cardiothorac Surg. 2020 Aug 1;58(2):261-268. doi: 10.1093/ejcts/ezaa040.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aditya K Kaza principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fluorescite and Cellvizio 100 Series System with Confocal Miniprobes in people with Atrial Septal Defect, run by Aditya Kaza at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced Adverse Events Possibly Related to Study Intervention (time frame: Surgery through discharge (approximately 5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03189134, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.