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

Completed

• Conditions: Pulmonary Hypertension Group 1 and 4 According to Nice Classification

• Registration Number: NCT01977014
• Lead Sponsor: NordicInfu Care AB

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (8)

Department of Cardiology, Aarhus University Hospital, Skejby; 🇩🇰 Aarhus, Denmark

Department of Cardiology Rigshospitalet University Hospital; 🇩🇰 Copenhagen, Denmark

Department of Cardiology, St Olav University Hospital; 🇳🇴 Trondheim, Norway

Department of Cardiology Oslo University Hospital, Rikshospitalet; 🇳🇴 Oslo, Norway

Department of Cardiology University Hospital in Linköping; 🇸🇪 Linköping, Sweden

Skane Univerity Hospital, Lund; 🇸🇪 Lund, Sweden

Karolinska Univerity Hospital, Solna; 🇸🇪 Stockholm, Sweden

Department of Cardiology Uppsala Akademiska University Hospital; 🇸🇪 Uppsala, Sweden