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NCT04696289 · ClinicalTrials.gov registry record · NA

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

A NA study of Pulmonary Vein Stenosis, sponsored by Boston Children's Hospital.

Active
Registry status
NA
Development phase
80
Enrollment target
1
Study location

NCT04696289 is a NA study of Pulmonary Vein Stenosis that is active but no longer recruiting, run by Boston Children's Hospital. The registered enrollment target is 80 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT04696289, a NA study of Pulmonary Vein Stenosis, is active but no longer recruiting, sponsored by Boston Children's Hospital.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
80 participants
Enrollment target
1
Study location

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 Studied

Interventions

  • DIAGNOSTIC_TEST Standardized catheterization assessment

Study Locations (1)

Massachusetts

  • Boston Children's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2021-02-26
Est. Completion 2026-12
Phase NA

Sponsor

Boston Children's Hospital

462 total trials

What the Registry Record Tells You About NCT04696289

The ClinicalTrials.gov registry entry for NCT04696289 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pulmonary Vein Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Standardized catheterization assessment is the first listed.

NCT04696289 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT04696289 about?

NCT04696289 is a clinical study titled "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, ea...

What is the current status of trial NCT04696289?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2021-02-26. Estimated completion is 2026-12.

What conditions does trial NCT04696289 study?

This clinical trial studies the following conditions: Pulmonary Vein Stenosis.

What interventions are being tested in trial NCT04696289?

The interventions under investigation include: Standardized catheterization assessment (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT04696289?

This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04696289 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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