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

NCT01977014 | Completed DMC

• 1 other identifier: NIMS/PAH/LP/001
• Study Type: observational
• Target: 40
• Locations: 3 countries
• Sites: 8

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.

Conditions

Pulmonary Hypertension Group 1 and 4 According to Nice Classification

Outcome Measures

Primary Outcomes (2)

• 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.

  Patient reported outcome measures, mainly CAMPHOR and SF-36

  Up to 3,5 years

Secondary Outcomes (1)

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

  Up to 3,5 years

Study Arms (1)

Patient with LenusPro pump

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in Scandinavia who received a LenusPro pump

You may qualify if:

• The patient should have been diagnosed with Pulmonary Arterial Hypertension
• The patient has received or will receive treatment with the implanted pump LenusPro

You may not qualify if:

• The patient is participating in another study which means treatment of the patient no longer follows the normal clinical practice

Sponsors & Collaborators

• NordicInfu Care AB: lead

Study Sites (8)

Department of Cardiology, Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark

Location

Department of Cardiology Rigshospitalet University Hospital

Copenhagen, Denmark

Location

Department of Cardiology Oslo University Hospital, Rikshospitalet

Oslo, 0424, Norway

Location

Department of Cardiology, St Olav University Hospital

Trondheim, 7006, Norway

Location

Department of Cardiology University Hospital in Linköping

Linköping, 581 85, Sweden

Location

Skane Univerity Hospital, Lund

Lund, 221 85, Sweden

Location

Karolinska Univerity Hospital, Solna

Stockholm, 171 76, Sweden

Location

Department of Cardiology Uppsala Akademiska University Hospital

Uppsala, 75185, Sweden

Location

Study Officials

• Jorn Carlsen, MD

  Department of Cardiology, Rigshospitalet in Copenhagen

  PRINCIPAL INVESTIGATOR

• Gerhard Vikstrom, MD

  Department of Cardiology, Uppsala Akademiska University Hospital

  PRINCIPAL INVESTIGATOR

• Arne Andreassen, MD

  Department of Cardiology, Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 4 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: November 6, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 7, 2017

Record last verified: 2017-07

Locations

DK (2); NO (2); SE (4)