80 Participants Needed

Standardized Catheterization Assessment for Pulmonary Vein Stenosis

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RC
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JE
Overseen ByJesse Esch, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the idea that Standardized Catheterization Assessment for Pulmonary Vein Stenosis is an effective treatment?

The available research does not provide specific data supporting the effectiveness of Standardized Catheterization Assessment for Pulmonary Vein Stenosis. The articles focus on the use of catheterization for other purposes, such as diagnosing heart conditions and improving quality in cardiac procedures, but do not directly address its effectiveness for treating Pulmonary Vein Stenosis.12345

What data supports the effectiveness of the treatment Standardized catheterization assessment for Pulmonary Vein Stenosis?

The research highlights the importance of quality management and continuous quality improvement in cardiac catheterization, which can enhance patient safety and optimize outcomes. This suggests that a standardized approach to catheterization, as part of a quality improvement initiative, may improve the effectiveness of the treatment for conditions like pulmonary vein stenosis.12345

What safety data is available for standardized catheterization assessment for pulmonary vein stenosis?

The safety data for transcatheter pulmonary vein interventions, which may include standardized catheterization assessments, indicates that serious adverse events occur in 12% of cases, with the most common being pulmonary hemorrhage and arrhythmia. Severe or catastrophic adverse events, such as strokes and patient death, occur in 1.7% of cases. Factors like age under 6 months and low systemic arterial saturation increase the risk of adverse events. This data is based on a retrospective cohort analysis of 240 patients who underwent 841 catheterizations from 2014 to 2021.678910

Is standardized catheterization assessment generally safe for humans?

Standardized catheterization procedures, like those used for pulmonary vein stenosis, have been associated with some risks. In a study of 841 procedures, serious adverse events occurred in 12% of cases, including pulmonary bleeding and irregular heartbeats, with severe events like strokes and one death in 1.7% of cases.678910

Is the treatment 'Standardized catheterization assessment' a promising treatment for Pulmonary Vein Stenosis?

Yes, standardized catheterization assessment is a promising treatment because it helps doctors better understand heart and lung conditions by providing detailed measurements of heart pressures and blood flow. This can lead to more accurate diagnoses and improved treatment plans for conditions like pulmonary vein stenosis.134811

How is the standardized catheterization assessment treatment different from other treatments for pulmonary vein stenosis?

The standardized catheterization assessment is unique because it provides a comprehensive evaluation of heart and lung pressures using a catheter, which helps in understanding the condition better and tailoring treatment. Unlike other treatments, it focuses on detailed hemodynamic measurements to guide therapy decisions, especially in complex cases like pulmonary vein stenosis.134811

What is the purpose of this trial?

This is a prospective, single center study which applies a standardized, comprehensive catheterization assessment to patients with a known or suspected diagnosis of pulmonary vein stenosis (PVS) who are undergoing a cardiac catheterization at Boston Children's Hospital. As part of the assessment, each pulmonary vein will undergo angiography (pictures using moving x-rays and contrast dye), intravascular ultrasound (IVUS; pictures of the vein wall using a catheter inside the vein), pressure assessment and compliance testing. The status of each pulmonary vein will then be assessed 12 months after the catheterization (i.e. no disease, severe disease, etc.). Using statistics, the investigators will determine which patient and vein characteristics (obtained at the of catheterization) can predict whether or not a pulmonary vein will have disease. The investigators hypothesize that this comprehensive, standardized, invasive assessment of pediatric intraluminal PVS can predict vein outcome.

Research Team

JE

Jesse Esch, MD

Principal Investigator

Boston Children's Hospital/Harvard Medical School

Eligibility Criteria

This trial is for pediatric patients who are suspected to have or are known to have pulmonary vein stenosis (PVS) and are stable enough to undergo a cardiac catheterization at Boston Children's Hospital.

Inclusion Criteria

My child is having a heart procedure to check for narrowed lung veins.

Exclusion Criteria

Hemodynamically unstable patients as determined by the patient care team.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Catheterization Assessment

Participants undergo a comprehensive catheterization assessment including angiography, intravascular ultrasound, pressure assessment, and compliance testing

1 day
1 visit (in-person)

Follow-up

Participants are monitored for pulmonary vein status and transplant-free survival

12 months
Periodic assessments

Treatment Details

Interventions

  • Standardized catheterization assessment
Trial Overview The study tests a comprehensive catheterization assessment during cardiac catheterization, including angiography, intravascular ultrasound, pressure measurement, and compliance testing. The goal is to predict PVS outcomes in children.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Standardized catheterization assessmentExperimental Treatment1 Intervention
Assessment of pulmonary veins including angiography, intravascular ultrasound, pressure assessment and compliance testing.

Standardized catheterization assessment is already approved in United States for the following indications:

🇺🇸
Approved in United States as Standardized catheterization assessment for:
  • Diagnosis and assessment of pediatric pulmonary vein stenosis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

Children's Hospital of Philadelphia

Collaborator

Trials
749
Recruited
11,400,000+

Findings from Research

Pulmonary artery catheterization is a valuable diagnostic tool that helps measure various heart pressures and cardiac output, providing insights into conditions like heart failure and pulmonary hypertension.
The review highlights the challenges in accurately assessing hemodynamic measurements due to varying techniques, which can affect clinical decisions and management strategies.
Right heart catheterization in clinical practice: a review of basic physiology and important issues relevant to interpretation.Del Rio-Pertuz, G., Nugent, K., Argueta-Sosa, E.[2023]
Quality assurance (QA) and quality improvement (QI) initiatives in cardiac catheterization laboratories are essential for enhancing patient safety and optimizing interactions between patients and healthcare teams.
National registries and appropriate use criteria (AUC) for revascularization are key tools for benchmarking performance and ensuring that medical procedures are used effectively, especially in the context of value-based healthcare.
Quality management in the cardiac catheterization laboratory.Henien, S., Aronow, HD., Abbott, JD.[2020]
In a study of 513 patients with acute lung injury, physical examination findings like cool extremities and knee mottling were found to have high specificity but low sensitivity for predicting low cardiac index and mixed venous oxygen saturation, indicating they are not reliable indicators of ineffective circulation.
Central venous oxygen saturation levels below 70% were associated with low mixed venous oxygen saturation, but a level of 70% or higher could effectively rule out the risk of low mixed venous oxygen saturation, suggesting it may be a useful measure in clinical assessments.
Association of physical examination with pulmonary artery catheter parameters in acute lung injury.Grissom, CK., Morris, AH., Lanken, PN., et al.[2021]

References

Right heart catheterization in clinical practice: a review of basic physiology and important issues relevant to interpretation. [2023]
Quality management in the cardiac catheterization laboratory. [2020]
Association of physical examination with pulmonary artery catheter parameters in acute lung injury. [2021]
Pulmonary Artery Catheter Usage and Impact on Mortality in Patients with Cardiogenic Shock: Results from a Canadian, Single Centre Registry. [2023]
Guidelines for continuous quality improvement in the cardiac catheterization laboratory. Laboratory Performance Standards Committee of the Society for Cardiac Angiography & Interventions. [2019]
Incidents and complications during pediatric cardiac catheterization. [2012]
Predictors of Serious Adverse Events and High-Level Cardiorespiratory Support in Patients Undergoing Transcatheter Pulmonary Vein Interventions. [2023]
Risk Factors for Major Early Adverse Events Related to Cardiac Catheterization in Children and Young Adults With Pulmonary Hypertension: An Analysis of Data From the IMPACT (Improving Adult and Congenital Treatment) Registry. [2020]
Pulmonary artery catheterization and clinical outcomes: National Heart, Lung, and Blood Institute and Food and Drug Administration Workshop Report. Consensus Statement. [2022]
[Adverse events during diagnostic and therapeutic pediatric cardiac catheterization]. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Predictors of Catastrophic Adverse Outcomes in Children With Pulmonary Hypertension Undergoing Cardiac Catheterization: A Multi-Institutional Analysis From the Pediatric Health Information Systems Database. [2018]
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