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

Information source: NordicInfu Care AB
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Hypertension Group 1 and 4 According to Nice Classification.

Phase: N/A

Status: Recruiting

Sponsored by: NordicInfu Care AB

Official(s) and/or principal investigator(s):
Jorn Carlsen, MD, Principal Investigator, Affiliation: Department of Cardiology, Rigshospitalet in Copenhagen
Gerhard Vikstrom, MD, Principal Investigator, Affiliation: Department of Cardiology, Uppsala Akademiska University Hospital
Arne Andreassen, MD, Principal Investigator, Affiliation: Department of Cardiology, Oslo University Hospital

Overall contact:
Gerhard Vikstrom, Phone: +46186110000, Email: gerhard.vikstrom@akademiska.se

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.

Clinical Details

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

Study design: Observational Model: Cohort

Primary outcome:

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

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

Secondary outcome: Description of baseline and follow-up of hemodynamic and functional capacity.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Gerhard Vikstrom, Phone: +46186110000, Email: gerhard.vikstrom@akademiska.se

Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus 8200, Denmark; Recruiting
Jens Erik Nielsen-Kudsk, MD
Jens Erik Nielsen-Kudsk, MD, Sub-Investigator
Soren Mellemkjaer, MD, Principal Investigator

Department of Cardiology Rigshospitalet University Hospital, Copenhagen, Denmark; Recruiting
Jørn Carlsen, MD, Phone: +4535453545
Jørn Carlsen, MD, Principal Investigator

Department of Cardiology Oslo University Hospital, Rikshospitalet, Oslo 0424, Norway; Recruiting
Arne Andreassen, MD, Phone: +47 915 02770
Arne Andreassen, MD, Principal Investigator

Department of Cardiology, St Olav University Hospital, Trondheim 7006, Norway; Recruiting
Marcel Moufack, MD
Marcel Moufack, MD, Principal Investigator

Department of Cardiology University Hospital in Linköping, Linköping 581 85, Sweden; Recruiting
Laila Hübbert, MD, Phone: +46 (0)10103 00 00
Laila Hübbert, MD, Principal Investigator

Skane Univerity Hospital, Lund, Lund 221 85, Sweden; Recruiting
Göran Rådegran, MD
Göran Rådegran, MD, Principal Investigator

Karolinska Univerity Hospital, Solna, Stockholm 171 76, Sweden; Recruiting
Magnus Nisell, MD
Magnus Nisell, MD, Principal Investigator

Department of Cardiology Uppsala Akademiska University Hospital, Uppsala 75185, Sweden; Recruiting
Gerhard Vikstrom, MD, Phone: +46186110000
Gerhard Vikstrom, MD, Principal Investigator

Additional Information

Starting date: October 2013
Last updated: December 9, 2013

Page last updated: August 23, 2015

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