NIMS- New Implantable Pump in Pulmonary Arterial Hypertension, a Safety Follow up

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01977014

Enrollment

Registered

2013-11-06

Start date

2013-10-31

Completion date

2016-12-31

Last updated

2017-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension Group 1 and 4 According to Nice Classification

Brief summary

This observational study aims to chart patients which get their prostacyclin treatment via the subcutaneous LenusPro pump. How the surgical procedure is performed and the clinical follow-up of these patients. And by this also charting complications that might occur in relation to treatment. Participating centres are located in Denmark, Norway and Sweden.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* The patient should have been diagnosed with Pulmonary Arterial Hypertension * The patient has received or will receive treatment with the implanted pump LenusPro

Exclusion criteria

* The patient is participating in another study which means treatment of the patient no longer follows the normal clinical practice

Design outcomes

Primary

Measure	Time frame	Description
Number and severity of events reported for the Lenus Pro in a clinical environment.	Up to 3,5 years	—
Changes in baseline variables during follow-up on quality of life.	Up to 3,5 years	Patient reported outcome measures, mainly CAMPHOR and SF-36

Secondary

Measure	Time frame	Description
Description of baseline and follow-up of hemodynamic and functional capacity.	Up to 3,5 years	Mainly right hearth catheterization, echo and 6MWD data.

Countries

Denmark, Norway, Sweden

Outcome results