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NCT03441971 · ClinicalTrials.gov registry record · NA

Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction

A NA study of Heart Defects, Congenital and Tetralogy of Fallot, sponsored by W.L.Gore & Associates.

Active
Registry status
NA
Development phase
15
Enrollment target
3
Study locations

NCT03441971 is a NA study of Heart Defects, Congenital and Tetralogy of Fallot that is active but no longer recruiting, run by W.L.Gore & Associates. The registered enrollment target is 15 participants, below the 362-participant average among 9 other Heart Defects, Congenital trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT03441971, a NA study of Heart Defects, Congenital and Tetralogy of Fallot, is active but no longer recruiting, sponsored by W.L.Gore & Associates.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
15 participants
Enrollment target
3
Study locations

Study Summary

This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).

Conditions Studied

Heart Defects, Congenital Tetralogy of Fallot Pulmonary Valve Insufficiency Pulmonary Valve Stenosis

Interventions

  • DEVICE GORE PV1

Study Locations (3)

Illinois

  • Lurie Children's Hospital - Chicago

Massachusetts

  • Boston Children's Hospital - Boston

Ohio

  • Nationwide Children's Hospital - Columbus

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2018-06-07
Est. Completion 2030-03
Phase NA

Sponsor

W.L.Gore & Associates

53 total trials

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What the Registry Record Tells You About NCT03441971

The ClinicalTrials.gov registry entry for NCT03441971 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 362-participant average among 9 other Heart Defects, Congenital trials with a reported enrollment target (96% lower). The listed sponsor is W.L.Gore & Associates, which has 53 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Heart Defects, Congenital appearing as the primary indexed condition, and to 1 intervention - of which GORE PV1 is the first listed.

NCT03441971 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Illinois, Massachusetts, Ohio.

Frequently Asked Questions

What is clinical trial NCT03441971 about?

NCT03441971 is a clinical study titled "Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction". This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).

What is the current status of trial NCT03441971?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2018-06-07. Estimated completion is 2030-03.

What conditions does trial NCT03441971 study?

This clinical trial studies the following conditions: Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis.

What interventions are being tested in trial NCT03441971?

The interventions under investigation include: GORE PV1 (DEVICE).

Who is sponsoring clinical trial NCT03441971?

This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03441971 being conducted?

This trial has 3 study locations across Illinois, Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.