Pulmonary Hypertension Group 1 and 4 According to Nice Classification Clinical Trial
Official title:
NIMS- New Implantable Pump in Pulmonary Arterial Hypertension, a Safety Follow up
| Verified date | July 2017 |
| Source | NordicInfu Care AB |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Department of Cardiology, Aarhus University Hospital, Skejby | Aarhus | |
| Denmark | Department of Cardiology Rigshospitalet University Hospital | Copenhagen | |
| Norway | Department of Cardiology Oslo University Hospital, Rikshospitalet | Oslo | |
| Norway | Department of Cardiology, St Olav University Hospital | Trondheim | |
| Sweden | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| NordicInfu Care AB |
Denmark, Norway, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number and severity of events reported for the Lenus Pro in a clinical environment. | Up to 3,5 years | ||
| Primary | 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 | Description of baseline and follow-up of hemodynamic and functional capacity. | Mainly right hearth catheterization, echo and 6MWD data. | Up to 3,5 years |