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

N/ACompletedNCT01977014

NordicInfu Care AB40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pulmonary Hypertension Group 1 and 4 According to Nice Classification

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (8)

Department of Cardiology, Aarhus University Hospital, Skejby

Aarhus, Denmark

Department of Cardiology Rigshospitalet University Hospital

Copenhagen, Denmark

Department of Cardiology Oslo University Hospital, Rikshospitalet

Oslo, Norway

Department of Cardiology, St Olav University Hospital

Outcomes

Primary Outcomes

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

Time frame: Up to 3,5 years

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

Patient reported outcome measures, mainly CAMPHOR and SF-36

Time frame: Up to 3,5 years

Secondary Outcomes

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

Mainly right hearth catheterization, echo and 6MWD data.

Time frame: Up to 3,5 years

Data from ClinicalTrials.gov

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