Standardized Catheterization Assessment for Pulmonary Vein Stenosis
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Catheterization Assessment
Participants undergo a comprehensive catheterization assessment including angiography, intravascular ultrasound, pressure assessment, and compliance testing
Follow-up
Participants are monitored for pulmonary vein status and transplant-free survival
Treatment Details
Interventions
- Standardized catheterization assessment
Standardized catheterization assessment is already approved in United States for the following indications:
- 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
Children's Hospital of Philadelphia
Collaborator