Observation Study With Implantable Medication Pump for Intravenous Treprostinil Therapy in Patients With Pulmonary Arterial Hypertension

NCT04309838 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2020-03-16

No results posted yet for this study

Summary

The study is designed as a non-interventional, multicenter, prospective single-arm study to observe the therapy with REMODULIN (Treprostinil) applicated by an implantable pump in patients with pulmonary arterial hypertension (PAH).

Conditions

Interventions

COMBINATION_PRODUCT

Treprostinil via implanted pump

Patients, diagnosed with PAH classified in stagnating intermediate-risk status after triple therapy including Selexipag for at least three months will receive the implantation of LENUS pro that enables permanent infusion of Treprostinil.

Sponsors & Collaborators

  • OMT GmbH & Co. KG

    collaborator UNKNOWN
  • University Medicine Greifswald

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2021-03-31
Completion
2021-12-31

Countries

  • Germany

Study Locations

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Entities

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 NCT04309838 on ClinicalTrials.gov