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

NCT ID: NCT01977014

Last Updated: 2017-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Pulmonary Hypertension Group 1 and 4 According to Nice Classification

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patient with LenusPro pump

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NordicInfu Care AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jorn Carlsen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Rigshospitalet in Copenhagen

Gerhard Vikstrom, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Uppsala Akademiska University Hospital

Arne Andreassen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Oslo University Hospital

Locations

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Department of Cardiology, Aarhus University Hospital, Skejby

Aarhus, , Denmark

Site Status

Department of Cardiology Rigshospitalet University Hospital

Copenhagen, , Denmark

Site Status

Department of Cardiology Oslo University Hospital, Rikshospitalet

Oslo, , Norway

Site Status

Department of Cardiology, St Olav University Hospital

Trondheim, , Norway

Site Status

Department of Cardiology University Hospital in Linköping

Linköping, , Sweden

Site Status

Skane Univerity Hospital, Lund

Lund, , Sweden

Site Status

Karolinska Univerity Hospital, Solna

Stockholm, , Sweden

Site Status

Department of Cardiology Uppsala Akademiska University Hospital

Uppsala, , Sweden

Site Status

Countries

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Denmark Norway Sweden

Other Identifiers

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NIMS/PAH/LP/001

Identifier Type: -

Identifier Source: org_study_id

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