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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: Active NA study of Pulmonary Vein Stenosis, sponsored by Boston Children's Hospital.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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).
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Standardized catheterization assessment
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2021-02-26 |
| Est. Completion | 2026-12 |
| Phase | NA |
What the registry record for NCT04696289 still lists
NCT04696289 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04696289's enrollment target sits among peer trials
80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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