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Implantable System for Remodulin Post-Approval Study

NCT03833323 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2021-07-02

No results posted yet for this study

Summary

The purpose of the Implantable System for Remodulin (ISR) Post Approval Study (PAS) is to provide evaluation and periodic reporting of the safety and effectiveness of Medtronic market-released ISR, including the catheter and the pump.

Conditions

Interventions

COMBINATION_PRODUCT

Implantable System for Remodulin (treprostinil)

All patients will be implanted with the Implantable System for Remodulin (treprostinil).

Sponsors & Collaborators

  • United Therapeutics

    collaborator INDUSTRY

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Robert Bourge, MD · University of Alabama at Birmingham

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-06-30
Completion
2021-06-30
FDA Drug
Yes
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03833323 on ClinicalTrials.gov