Cellvizio 100 Series System with Confocal Miniprobes for Ventricular Septal Defects (VSD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Boston Children's Hospital, Boston, MA
Ventricular Septal Defects (VSD)+6 More
Cellvizio 100 Series System with Confocal Miniprobes - Device
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether fiberoptic confocal microscopy may help surgeons avoid conduction abnormalities during heart surgery.

See full description

Eligible Conditions

  • Ventricular Septal Defects (VSD)
  • Tetralogy of Fallot With Pulmonary Stenosis
  • Complete Atrioventricular Canal

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Cellvizio 100 Series System with Confocal Miniprobes will improve 1 primary outcome and 10 secondary outcomes in patients with Ventricular Septal Defects (VSD). Measurement will happen over the course of 1 day.

1 day
Ease of use
Need for repeat bypass
1 year post-surgery
Adverse events
Change in PR interval
Change in QTc interval
Degree of heart block
Pacemaker implantation
Year 1
Change in QRS interval
Immediately post-surgery
Rate of new conduction disorders
Day 5
Residual lesion score (RLS) at discharge
Time to temporary pacing wire removal prior to discharge

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Non-imaging cohort
1 of 2
Imaging cohort
1 of 2
Active Control
Experimental Treatment

This trial requires 70 total participants across 2 different treatment groups

This trial involves 2 different treatments. Cellvizio 100 Series System With Confocal Miniprobes is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Imaging cohortUp 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.
Non-imaging cohortThere will be no intervention for the non-imaging group. Subjects will receive standard of care for cardiac surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cellvizio 100 Series System with Confocal Miniprobes
2018
Completed Phase 1
~10
Fluorescein
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year post-surgery
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year post-surgery for reporting.

Closest Location

Boston Children's Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 30 days to less than 18 years old
Ventricular septal defect (VSD)
Complete atrioventricular canal (CAVC)
Tetralogy of Fallot (ToF) with pulmonary stenosis

Patient Q&A Section

How many people get heart septal defects, ventricular a year in the United States?

"It is unlikely that you would find the prevalence of heart septal defects, ventricular a year reported in the U.S. In fact, one of the highest incidences reported in the literature for this anomaly is found in the U.S. The number of infants reported to have this type of heart anomaly appears to be higher than the reports from any of the other countries surveyed." - Anonymous Online Contributor

Unverified Answer

What causes heart septal defects, ventricular?

"Ventricular septal defects are usually caused by a combination of genetic risk and environmental risk factors, and heart disease can be a manifestation of a prior condition, especially in a genetic manner." - Anonymous Online Contributor

Unverified Answer

What are the signs of heart septal defects, ventricular?

"Patients with heart septal defects manifest the following signs: 1) a history of unexplained collapse, loss of consciousness, cyanosis or syncope; 2) arrhythmia and syncope as signs of pericarditis and 3) a high pretest probability for mitral stenosis or" - Anonymous Online Contributor

Unverified Answer

What are common treatments for heart septal defects, ventricular?

"The first of these procedures is percutaneous closure in newborns with right ventricular shunting. The majority of adults will require surgical repair, and some will require heart transplantation. Ventricular support and inotropic agents are used for the acute management of heart failure. Cardiopulmonary bypass may be necessary with right ventricular heart grafts or the palliation of congenital heart disease." - Anonymous Online Contributor

Unverified Answer

What is heart septal defects, ventricular?

"Ventricular septal defects are a rare cause of heart defects in newborns and infants. They are named for the resemblance of the defect to the septal portion of the heart, hence the name ventricular defect. They are typically recognized by an echocardiogram, but even then prompt evaluation is required, considering the potential fatal effects of these defects in the newborn.\n\n- A.C.R.M.S.: The Australian Consortium for Research in Mental and Neuropsychiatric Disorders, a comprehensive initiative between leading Australian, and other Western Australian academic organisations.\n- B.M.F.M." - Anonymous Online Contributor

Unverified Answer

Can heart septal defects, ventricular be cured?

"There is some hope of long-term outcome of heart septal defects, particularly in infants at risk of atrial septal defects or sepsis. The prognosis in these patients is very poor in the short term. Follow-up is essential, and the possibility of heart transplantation should be considered." - Anonymous Online Contributor

Unverified Answer

How serious can heart septal defects, ventricular be?

"The overall mortality rate was 8%; however, it varied significantly depending on the heart defect. The patients with heart defects had a higher mortality than those without. Mortality risk was also higher in females than in males, even after adjusting for comorbidities." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for heart septal defects, ventricular?

"Heart septal defects and ventricular can be treated with catheter ablation with minimal risks. Patients who require a second intervention should consider clinical trials as they have a higher risk of septal re-dissection." - Anonymous Online Contributor

Unverified Answer

Does heart septal defects, ventricular run in families?

"Data from a recent study indicate that this family is part of a much-considered familial entity that probably has both X chromosome and autosomal-recessive inheritance. The combination of congenital heart defects and immunodefects might also occur in other autosomal-recessive defects. This report should be considered as another clinical example of X linkage-based transmission of heart defects in an XO-related family." - Anonymous Online Contributor

Unverified Answer

How does cellvizio 100 series system with confocal miniprobes work?

"Cellvizio 100 series with a confocal miniprobe is an invaluable tool for intraoperative IOL sizing at the time of DSA. The system can be used for other intraocular surgeries with potential short-term or long-term applications, such as cataract surgery, laser eye surgery, and glaucoma surgery." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of cellvizio 100 series system with confocal miniprobes?

"Miniprobe system with C-system enables visualization of cellular structures in vivo and gives a reliable understanding of the cardiac tissue. The application of CVS confers a great benefit in improving the accuracy and facilitating the comprehension of the structure and function of the heart. The CVS system can be used as a convenient and accessible non-invasive device for imaging of the heart." - Anonymous Online Contributor

Unverified Answer

What is cellvizio 100 series system with confocal miniprobes?

"There was no significant difference in endocardial viability with or without the Cellvizio 100 series confocal miniprobe. A 2.5-fold smaller volume of sample was required with the Cellvizio 100 series system compared to the Cellvizio 100-V system. Overall, this system is an advantageous option for evaluating endocardial viability compared to the Cellvizio 100 system." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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