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NCT01321073 · ClinicalTrials.gov registry record · NA

DelIVery for Pulmonary Arterial Hypertension (PAH) & Continued Support Study

A NA study of Pulmonary Arterial Hypertension, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

Active
Registry status
NA
Development phase
64
Enrollment target
8
Study locations

NCT01321073 is a NA study of Pulmonary Arterial Hypertension that is active but no longer recruiting, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 64 participants, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (86% lower). The trial reports 8 study locations across 8 states.

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The verdict

NCT01321073, a NA study of Pulmonary Arterial Hypertension, is active but no longer recruiting, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
64 participants
Enrollment target
8
Study locations

Study Summary

The purpose of the DelIVery for PAH clinical study is to evaluate the safety of the Medtronic Model 10642 Implantable Intravascular Catheter when used with the Medtronic SynchroMed® II Implantable Infusion System to deliver Remodulin® (treprostinil) Injection. As of June 2021, PMA approval of the Implantable System for Remodulin (ISR) is no longer being pursued and development and commercialization efforts have been halted. The approximately 30 subjects still implanted with the PIVoT system require a pathway for continued support. This protocol is amended and is designed to allow such ongoing support.

Conditions Studied

Pulmonary Arterial Hypertension

Interventions

  • DEVICE Model 10642 Implantable Intravascular Catheter

Study Locations (8)

Alabama

  • University of Alabama at Birmingham - Birmingham

California

  • VA Greater Los Angeles Healthcare System - Los Angeles

Florida

  • AdventHealth Orlando - Orlando

Illinois

  • University of Chicago Medical Center - Chicago

Massachusetts

  • Brigham & Women's Hospital - Boston

Minnesota

  • Mayo Clinic - Rochester

Texas

  • University of Texas Southwestern Medical Center - Dallas

Wisconsin

  • Aurora St. Lukes Medical Center - Milwaukee

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2011-06
Est. Completion 2032-12
Phase NA

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

115 total trials

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What the Registry Record Tells You About NCT01321073

The ClinicalTrials.gov registry entry for NCT01321073 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (86% lower). The listed sponsor is Medtronic Cardiac Rhythm and Heart Failure, which has 115 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Model 10642 Implantable Intravascular Catheter is the first listed.

NCT01321073 reports 8 study locations spanning 8 distinct geographic areas - top geographies include Alabama, California, Florida.

Frequently Asked Questions

What is clinical trial NCT01321073 about?

NCT01321073 is a clinical study titled "DelIVery for Pulmonary Arterial Hypertension (PAH) & Continued Support Study". The purpose of the DelIVery for PAH clinical study is to evaluate the safety of the Medtronic Model 10642 Implantable Intravascular Catheter when used with the Medtronic SynchroMed® II Implantable Infusion System to deliver Remodulin® (treprostinil) Injection. As of June 2021, PMA approval of the I...

What is the current status of trial NCT01321073?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 64 participants. The study started on 2011-06. Estimated completion is 2032-12.

What conditions does trial NCT01321073 study?

This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.

What interventions are being tested in trial NCT01321073?

The interventions under investigation include: Model 10642 Implantable Intravascular Catheter (DEVICE).

Who is sponsoring clinical trial NCT01321073?

This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01321073 being conducted?

This trial has 8 study locations across Alabama, California, Florida, 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.