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NCT Number: NCT04696289

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standardized catheterization assessment

Diagnostic Test

There are four components to the pulmonary vein assessment.

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

Primary outcomes

  1. Pulmonary vein status

    Time frame: 12 months +/- 6 weeks or prior to study exit due to death or lung transplant

    Severity of pulmonary vein stenosis (score 0 to 3); Score 0: Unobstructed vein (best outcome), Score 1: Proximal vein disease, Score 2: Distal vein disease, Score 3: Vein atresia (worst outcome).

Secondary outcomes

  1. Patient status

    Time frame: 12 months

    Transplant free survival

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Children's Hospital of Philadelphia

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jan 6, 2021
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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