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
|