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ACTIVE NOT RECRUITING
NCT04696289
NA

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

Sponsor: Boston Children's Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Predicting Pediatric Intraluminal Pulmonary Vein Stenosis Outcomes Using a Comprehensive Standardized Catheterization Assessment

Key Details

Gender

All

Age Range

Any - 12 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2021-02-26

Completion Date

2026-12

Last Updated

2026-01-30

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Standardized catheterization assessment

There are four components to the pulmonary vein assessment. 1. Angiography: pulmonary artery wedge injection and/or selective pulmonary vein injection. 2. Intravascular ultrasound: manual pullback of IVUS catheter from lobar segment to left atrium. 3. Pressure assessment: pulmonary vein pressure (mmHg) measured before and after (if applicable) intervention. 4. Compliance testing: the compliance of the vein will be measured using a compliant conventional balloon.

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States