Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING NA

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

NCT01321073 · View on ClinicalTrials.gov ↗

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.

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01321073

The ClinicalTrials.gov registry entry for NCT01321073 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiac Rhythm and Heart Failure, which has 56 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01321073 reports 8 study locations spanning 8 distinct geographic areas — top geographies include Alabama, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01321073?

The interventions under investigation include: Model 10642 Implantable Intravascular Catheter (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01321073?

This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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