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OpenTrials
Completed

NCT Number: NCT01977014

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

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.

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Key information

Conditions

Pulmonary Hypertension Group 1 and 4 According to Nice Classification

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number and severity of events reported for the Lenus Pro in a clinical environment.

    Time frame: Up to 3,5 years

  2. Changes in baseline variables during follow-up on quality of life.

    Time frame: Up to 3,5 years

    Patient reported outcome measures, mainly CAMPHOR and SF-36

Secondary outcomes

  1. Description of baseline and follow-up of hemodynamic and functional capacity.

    Time frame: Up to 3,5 years

    Mainly right hearth catheterization, echo and 6MWD data.

Sponsors and collaborators

Lead sponsor

NordicInfu Care AB

Industry

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2013
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.