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NCT05006404 · ClinicalTrials.gov registry record · NA

Autus Valve Pivotal Study

A NA study of Congenital Heart Disease, sponsored by Autus Valve Technologies.

Active
Registry status
NA
Development phase
51
Enrollment target
12
Study locations

NCT05006404 is a NA study of Congenital Heart Disease that is active but no longer recruiting, run by Autus Valve Technologies. The registered enrollment target is 51 participants, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (89% lower). The trial reports 12 study locations across 12 states.

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The verdict

NCT05006404, a NA study of Congenital Heart Disease, is active but no longer recruiting, sponsored by Autus Valve Technologies.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
51 participants
Enrollment target
12
Study locations

Study Summary

Prospective, single-arm, multi-center study to evaluate safety and effectiveness of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement. The Autus Valve may be expanded pre-implant to match the subject's body size. Subjects will be evaluated prior to the Autus Valve implant procedure, immediately post-implant, at hospital discharge, 30 days, 6 months, and annually through 10 years. The Autus Valve may be expanded post-implant via transcatheter balloon dilation to accommodate growth of the subject. In subjects who undergo a post-implant valve expansion, follow-up will continue for a minimum of 1 year after the post-implant valve expansion procedure.

Conditions Studied

Congenital Heart Disease

Interventions

  • DEVICE Pulmonary Valve Replacement Surgery

Study Locations (12)

California

  • Children's Hospital Los Angeles - Los Angeles

Colorado

  • Children's Hospital Colorado - Aurora

Georgia

  • Children's Healthcare of Atlanta - Atlanta

Illinois

  • Ann and Robert H. Lurie Children's Hospital of Chicago - Chicago

Massachusetts

  • Boston Children's Hospital - Boston

Michigan

  • University of Michigan - Mott Children's Hospital - Ann Arbor

New York

  • Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's Hospital - New York

North Carolina

  • Duke University - Durham

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2024-02-05
Est. Completion 2036-02-05
Phase NA

Sponsor

Autus Valve Technologies

1 total trials

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What the Registry Record Tells You About NCT05006404

The ClinicalTrials.gov registry entry for NCT05006404 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (89% lower). The listed sponsor is Autus Valve Technologies, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which Pulmonary Valve Replacement Surgery is the first listed.

NCT05006404 reports 12 study locations spanning 12 distinct geographic areas - top geographies include California, Colorado, Georgia.

Frequently Asked Questions

What is clinical trial NCT05006404 about?

NCT05006404 is a clinical study titled "Autus Valve Pivotal Study". Prospective, single-arm, multi-center study to evaluate safety and effectiveness of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement. The Autus Valve may be expanded pre-implant to match the subject's body size. Subjects ...

What is the current status of trial NCT05006404?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 51 participants. The study started on 2024-02-05. Estimated completion is 2036-02-05.

What conditions does trial NCT05006404 study?

This clinical trial studies the following conditions: Congenital Heart Disease.

What interventions are being tested in trial NCT05006404?

The interventions under investigation include: Pulmonary Valve Replacement Surgery (DEVICE).

Who is sponsoring clinical trial NCT05006404?

This trial is sponsored by Autus Valve Technologies, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05006404 being conducted?

This trial has 12 study locations across California, Colorado, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.