Predicting Pediatric Pulmonary Vein Stenosis Outcomes Using Data Acquired During a Cardiac Catheterization

Boston Children's Hospital

Status: Active, not recruiting

Conditions: Pulmonary Vein Stenosis

Treatments: Diagnostic Test: Standardized catheterization assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT04696289

IRB-P00035534

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: Under 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric patients undergoing cardiac catheterization for the indication of known or suspicion for intraluminal pulmonary vein stenosis.

Exclusion criteria

• Hemodynamically unstable patients as determined by the patient care team.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Standardized catheterization assessment

Experimental group

Description:

Assessment of pulmonary veins including angiography, intravascular ultrasound, pressure assessment and compliance testing.

Treatment:

Diagnostic Test: Standardized catheterization assessment