MedTrace Logo

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

NCT04696289 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-30

No results posted yet for this study

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.

Conditions

  • Pulmonary Vein Stenosis

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.

Sponsors & Collaborators

Principal Investigators

  • Jesse Esch, MD · Boston Children's Hospital/Harvard Medical School

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-26
Primary Completion
2025-12-01
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04696289 on ClinicalTrials.gov