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Standardized Catheterization Assessment for Pulmonary Vein Stenosis
N/A
Recruiting
Led By Ryan Callahan, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pediatric patients undergoing cardiac catheterization for the indication of known or suspicion for intraluminal pulmonary vein stenosis.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months +/- 6 weeks or prior to study exit due to death or lung transplant
Awards & highlights
Study Summary
This trial is testing a new, standardized way to assess pulmonary vein stenosis (narrowing). They will do this by looking at pictures of the veins, measuring pressure and compliance, and then following up 12 months later to see if the disease progressed.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the document doesn't list specific side effects, procedures like angiography and IVUS may cause discomfort, bruising or bleeding where the catheter was inserted, allergic reactions to contrast dye used in imaging, or more rarely heart complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is having a heart procedure to check for narrowed lung veins.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months +/- 6 weeks or prior to study exit due to death or lung transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months +/- 6 weeks or prior to study exit due to death or lung transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pulmonary vein status
Secondary outcome measures
Patient status
Trial Design
1Treatment groups
Experimental Treatment
Group I: Standardized catheterization assessmentExperimental Treatment1 Intervention
Assessment of pulmonary veins including angiography, intravascular ultrasound, pressure assessment and compliance testing.
Find a Location
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
769 Previous Clinical Trials
5,580,449 Total Patients Enrolled
1 Trials studying Pulmonary Vein Stenosis
5 Patients Enrolled for Pulmonary Vein Stenosis
Children's Hospital of PhiladelphiaOTHER
710 Previous Clinical Trials
8,588,884 Total Patients Enrolled
Ryan Callahan, MDPrincipal InvestigatorBoston Children's Hospital/Harvard Medical School
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is having a heart procedure to check for narrowed lung veins.
Research Study Groups:
This trial has the following groups:- Group 1: Standardized catheterization assessment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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