Ventricular Septal DefectPhase 2OPTIMANCT04017975
Optical Tissue Identification for Myocardial Architecture
A Phase 2 study testing Fluorescite and Cellvizio 100 Series System with Confocal Miniprobes in people with Ventricular Septal Defect and Complete Atrioventricular Canal, run by Aditya Kaza at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 days to 18 years
- Conditions the study is for
- Ventricular Septal Defect, Complete Atrioventricular Canal, Tetralogy of Fallot With Pulmonary Stenosis
- 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
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2019to Sep 2023
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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 > 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
Show all 10Show fewer
- Pregnant or lactating
- Exclusions specific to type of surgical repair
- Apical muscular VSD
- ToF with pulmonary atresia
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Optical Tissue Identification for Myocardial Architecture (OPTIMA Study)
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.
Read the 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
- Ventricular Septal Defect, Complete Atrioventricular Canal, Tetralogy of Fallot With Pulmonary Stenosis
- Being tested
- Fluorescite, Cellvizio 100 Series System with Confocal Miniprobes
- Keywords
- fiberoptic confocal microscopy, cardiac surgery
- Medical subject headings
- Heart Septal Defects, Ventricular, Complete atrioventricular septal defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoresciteDrug
Also called fluorescein sodium
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.
Cellvizio 100 Series System with Confocal MiniprobesDevice
The microscopy system will image cardiac tissue.
| Study group | Role | What they receive |
|---|---|---|
| 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. 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.
Rate of new conduction disorders
Rate of new conduction disorders post-surgery will be determined by electrophysiologist read and compared between the two groups
Measured: Immediately post-surgery
Secondary outcomes (10)
Change in PR interval
PR interval will be compared between baseline, post-op, and 1 year follow up
Measured: 1 year post-surgery
Change in QTc interval
QTc interval will be compared between baseline, post-op, and 1 year follow up
Measured: 1 year post-surgery
Change in QRS interval
QRS interval will be compared between baseline, post-op, and 1 year follow up
Measured: 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
Measured: 1 year post-surgery
Pacemaker implantation
Incidence of temporary and permanent pacemaker implantation will be collected
Measured: 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
Measured: Surgery to discharge (approximately 5 days)
Residual lesion score (RLS) at discharge
RLS will be compared between groups
Measured: Surgery to discharge (approximately 5 days)
Need for repeat bypass
Need for repeat bypass for residual lesions during surgery will be collected
Measured: 1 day
Adverse events
Rates of adverse events will be collected and compared between the two group
Measured: 1 year post-surgery
Ease of use
Surgeon feedback regarding using the FCM system will be collected using a brief survey
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start20 Dec 2019
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized into two groups using permuted block and stratified according to type of surgical repair.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 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, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017975
- Sponsor's protocol ID
- P00031701
- Other IDs
- R56HL128813
- Acronym
- OPTIMA
- Status last verified
- Jun 2023
- First submitted
- 10 Jul 2019
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Tissue Identification for Myocardial Architecture (OPTIMA Study)
- ClinicalTrials.gov ID
- NCT04017975
- Acronym / sponsor ID
- OPTIMA / P00031701
- Conditions
- Ventricular Septal Defect, Complete Atrioventricular Canal, Tetralogy of Fallot With Pulmonary Stenosis
- Keywords
- fiberoptic confocal microscopy, cardiac surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aditya KazaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized into two groups using permuted block and stratified according to type of surgical repair.
| Arm | Type | Receives |
|---|---|---|
| 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 | 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. The system will be used to assist the investigator with the operative course. |
Who may qualify
- Ages
- 30 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 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 > 98% for age
- Underlying genetic syndrome associated with progressive AV block or 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 sodium1 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. | Drug | Imaging cohort |
| Cellvizio 100 Series System with Confocal MiniprobesThe microscopy system will image cardiac tissue. | Device | Imaging cohort |
Primary outcome
Rate of new conduction disorders
Time frame: Immediately post-surgery
Rate of new conduction disorders post-surgery will be determined by electrophysiologist read and compared between the two groups
10 secondary outcomes
Change in PR interval
Time frame: 1 year post-surgery
Change in QTc interval
Time frame: 1 year post-surgery
Change in QRS interval
Time frame: Approximately 5 days post-surgery and 1 year post-surgery
Degree of heart block
Time frame: 1 year post-surgery
Pacemaker implantation
Time frame: 1 year post-surgery
Time to temporary pacing wire removal prior to discharge
Time frame: Surgery to discharge (approximately 5 days)
Residual lesion score (RLS) at discharge
Time frame: Surgery to discharge (approximately 5 days)
Need for repeat bypass
Time frame: 1 day
Adverse events
Time frame: 1 year post-surgery
Ease of use
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data 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, MD 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 2 study testing Fluorescite and Cellvizio 100 Series System with Confocal Miniprobes in people with Ventricular Septal Defect and Complete Atrioventricular Canal, 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 5 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Rate of new conduction disorders (time frame: Immediately post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2023.