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NCT03924661 · ClinicalTrials.gov registry record

SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy

A clinical trial of Aortic Valve Disease, sponsored by Abbott Medical Devices.

Active
Registry status
20
Enrollment target
13
Study locations

NCT03924661 is a study of Aortic Valve Disease that is active but no longer recruiting, run by Abbott Medical Devices. The registered enrollment target is 20 participants, below the 18,616-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (100% lower). The trial reports 13 study locations across 10 states.

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The verdict

NCT03924661, a study of Aortic Valve Disease, is active but no longer recruiting, sponsored by Abbott Medical Devices.

ACTIVE NOT RECRUITING
Registry status
20 participants
Enrollment target
13
Study locations

Study Summary

This PAS is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve (15 AHPJ-505) as a replacement device for pediatric patients with a diseased, damaged, or malfunctioning aortic valve.

Conditions Studied

Aortic Valve Disease

Interventions

  • DEVICE Aortic Valve Replacement

Study Locations (13)

California

  • Children's Hospital Los Angeles (USC) - Los Angeles
  • Valley Children's Hospital - Madera
  • Sutter Medical Center, Sacramento - Sacramento

Texas

  • Dell Children's Medical Center - Austin
  • Children's Medical Center Dallas - Dallas

Florida

  • Variety Children's Hospital - Miami

Georgia

  • Children's Healthcare of Atlanta - Atlanta

Mississippi

  • University of Mississippi Medical Center - Jackson

Ohio

  • Cincinnati Children's Hospital - Cincinnati

Baden-Wurttemberg

  • Sana - Herzchirurgische Klinik Stuttgart GmbH - Stuttgart

Bavaria

  • Deutsches Herzzentrum München des Freistaates Bayern - München

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2019-10-24
Est. Completion 2028-10

Sponsor

Abbott Medical Devices

261 total trials

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What the Registry Record Tells You About NCT03924661

The ClinicalTrials.gov registry entry for NCT03924661 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 18,616-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (100% lower). The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.

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

NCT03924661 reports 13 study locations spanning 10 distinct geographic areas - top geographies include California, Texas, Florida.

Frequently Asked Questions

What is clinical trial NCT03924661 about?

NCT03924661 is a clinical study titled "SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy". This PAS is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve (15 AHPJ-505) as a replacement device for pediatric patients with a diseased, dama...

What is the current status of trial NCT03924661?

This trial is currently active not recruiting. The enrollment target is 20 participants. The study started on 2019-10-24. Estimated completion is 2028-10.

What conditions does trial NCT03924661 study?

This clinical trial studies the following conditions: Aortic Valve Disease.

What interventions are being tested in trial NCT03924661?

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

Who is sponsoring clinical trial NCT03924661?

This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03924661 being conducted?

This trial has 13 study locations across California, Florida, Georgia, Mississippi, 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.