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NCT02979587 · ClinicalTrials.gov registry record · NA

The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

A NA study of Congenital Heart Disease and Pulmonary Regurgitation, sponsored by Medtronic Heart Valves.

Active
Registry status
NA
Development phase
86
Enrollment target
12
Study locations

NCT02979587 is a NA study of Congenital Heart Disease and Pulmonary Regurgitation that is active but no longer recruiting, run by Medtronic Heart Valves. The registered enrollment target is 86 participants, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (82% lower). The trial reports 12 study locations across 10 states.

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The verdict

NCT02979587, a NA study of Congenital Heart Disease and Pulmonary Regurgitation, is active but no longer recruiting, sponsored by Medtronic Heart Valves.

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

Study Summary

The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.

Conditions Studied

Congenital Heart Disease Pulmonary Regurgitation Tetrology of Fallot RVOT Anomaly

Interventions

  • DEVICE Harmony TPV System

Study Locations (12)

California

  • Ronald Regan UCLA Medical Center - Los Angeles
  • Stanford University Medical Center - Palo Alto

Ontario

  • The Hospital for Sick Children (SickKids) - Toronto
  • Toronto General Hospital - Toronto

Connecticut

  • Yale University - New Haven

Minnesota

  • Mayo Clinic - Rochester

Ohio

  • Nationwide Children's Hospital - Columbus

Pennsylvania

  • The Children's Hospital of Philadelphia - Philadelphia

Texas

  • Texas Children's Hospital - Houston

Utah

  • Primary Children's Hospital - Salt Lake City

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2017-01
Est. Completion 2031-02
Phase NA

Sponsor

Medtronic Heart Valves

3 total trials

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What the Registry Record Tells You About NCT02979587

The ClinicalTrials.gov registry entry for NCT02979587 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 86 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 (82% lower). The listed sponsor is Medtronic Heart Valves, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which Harmony TPV System is the first listed.

NCT02979587 reports 12 study locations spanning 10 distinct geographic areas - top geographies include California, Ontario, Connecticut.

Frequently Asked Questions

What is clinical trial NCT02979587 about?

NCT02979587 is a clinical study titled "The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study". The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.

What is the current status of trial NCT02979587?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 86 participants. The study started on 2017-01. Estimated completion is 2031-02.

What conditions does trial NCT02979587 study?

This clinical trial studies the following conditions: Congenital Heart Disease, Pulmonary Regurgitation, Tetrology of Fallot, RVOT Anomaly.

What interventions are being tested in trial NCT02979587?

The interventions under investigation include: Harmony TPV System (DEVICE).

Who is sponsoring clinical trial NCT02979587?

This trial is sponsored by Medtronic Heart Valves, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02979587 being conducted?

This trial has 12 study locations across California, Connecticut, Minnesota, Ohio, Pennsylvania. 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.