LenusPro Safety (LPS) Study in Patients With PH

November 3, 2013 updated by: Prof. Ralf Ewert, University Medicine Greifswald

LPS (Lenus Pro Safety) - Study in Pulmonary Hypertension (PH)

The clinical study aims to investigate the numbers of predefined complications in the first six month after implantation of the implantable LENUS Pro® medications pump for intravenous application of treprostinil sodium in patients with PAH.

The manufacturer is Tricumed GmbH, Germany; exclusive marketing rights: OMT GmbH & Co KG 78665 Frittlingen, Germany.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The previously used fully implantable pumps have been improved by development of additional safety options (e.g. acoustic occlusion alarm) for use in patients with PH. In the meantime, the pump (manufacturer: Tricumed GmbH, Germany, exclusively marketing rights: OMT GmbH & Co KG, 78665 Frittlingen, Germany) is offered with an option that meets the requirements for use in treating PH patients. It is based on a constant flow system that consists of gas driven micro-infusion via a chip capillary. The medication is filled into a titanium reservoir via a so-called filling septum (silicon membrane). The membrane is punctured percutaneously with a special needle by specially trained personnel for filling under aseptic conditions. Various safety options ensure a continuous flow rate of the medication and signalize any malfunctions. If catheter occlusion is signalized, the catheter can be rinsed through a second septum in the pump after a percutaneous puncture without emptying the medication reservoir. The pump is available in two sizes (20 ml or 40 ml filling volume). The flow rate set for the 20 ml pump is 1.0 ml/ 24 hours, so that refilling is required every 19 to 20 days. The flow rate set for the 40 ml pump is 2.3 ml/ 24 hours, so that refilling is required every 29 to 30 days. Initial experience with the use of this pump has shown good results for up to 3 years of use (minor complications during implantation, no pump defects in long-term usage, reliable filling under outpatient conditions).

R. Ewert; M. Halank, L. Bruch; H.A. Ghofrani. The implantable pump - a new option for intravenous therapy in patients with severe pulmonary hypertension. Am J Respir Crit Care 2012;186:1196-98 Steringer-Mascherbauer R., Eder V., Ebner Ch. et al. First experience with intravenous treprostinil delivered by an implantable pump (Lenus Pro®) with filling intervals of 28 days in a patient with pulmonary arterial hypertension (PAH) - a case report. ATS Poster Desole S, Velik-Salchner C, Fraedrich G et al. Subcutaneous implantation of a new intravenous pump system for prostacyclin treatment in patients with pulmonary arterial hypertension. Heart Lung 2012 Aug 21. [Epub ahead of print]

Such pumps have been implanted in more than 90 patients in various European countries during the past 3 years. Experience shows that most of the patients selected for implantation have FC II-IV under combination therapy (2-3 specific PH-medications). The previous medication was either regarded as insufficient in respect to cardiopulmonary stabilization or the side effects of the therapy were intolerable. The latter applied particularly to patients with subcutaneous delivery of treprostinil in fairly large doses.

Given the previous application of the LENUS Pro® pump in the context of individualized healing attempts, the initiators of the planned study consider that it is necessary to ascertain the safety of this fully implantable pump system in a controlled prospective study.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, A- 4020
  • Germany
      • Giessen, Germany, D-35392
        • Recruiting
        • Universitatsklinik Giessen
        • Contact:
        • Principal Investigator:
          • Ardeschir Ghofrani, M.D.
      • Greifswald, Germany, 17489
        • Recruiting
        • University Hospital of Greifswald
        • Contact:
        • Principal Investigator:
          • Ralf Ewert, M.D.
  • Netherlands
      • Amsterdam, Netherlands, NL-1081
        • Not yet recruiting
        • VU University Medical Center
        • Contact:
        • Principal Investigator:
          • Anco Boonstra, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients from pulmonary centers

Description

Inclusion Criteria:

Patient Inclusion Criteria:

Patient aged ≥ 18 years Patient (or patient's legally authorized representative) is willing and able to provide written informed consent Patient is willing and able to comply with the protocol, including required follow-up visits Patient is diagnosed with Pulmonary Arterial Hypertension (World Health Organization (WHO) Category Group 1 (by the WHO Clinical classification system), including Idiopathic (IPAH), Heritable PAH (HPAH) (Familial PAH), and PAH associated with other diseases (APAH), Patient is receiving continuous infusion of treprostinil via subcutaneous or intravenous delivery using an external pump system Patient is in stable clinical condition und the previous specific PH medication has been retained unchanged during the past 3 weeks Patient's anticoagulation therapy can be managed to permit safe device implantation

Exclusion Criteria:

  • Pregnancy, nursing Women of childbearing potential who are not on a reliable and safe form of contraception Patient is diagnosed with PH with an etiology different from that of the inclusion criteria, Patient is diagnosed with chronic kidney disease (estimated GFR <30) within ninety (90) days prior to Baseline visit; chronic kidney disease is defined as that lasting or expected to last more than three (3) months.

Hepatic insufficiency (Child C) Patient is a person whose body size is not sufficient to accept implantable pump bulk and weight as determined by the implanting surgeon Unacceptably high anesthetic risk as determined by the treating anesthesiologist Concomitant medication or underlying disease associated with an increased infection risk (e.g., intravenous drug abuse, diabetic gangrene) Patient is not in stable condition, especially a manifestation of decompensated right heart failure within three weeks prior to Baseline visit Patients with significantly increased bleeding risk due to comorbidities (e.g. hereditary F VIII deficiency, myeloproliferative neoplasm) Estimated life expectancy < 6 months due to comorbidities (e.g. terminal malignancy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PH patients with LenusPro pump

Patient Inclusion Criteria:

  1. Patient aged ≥ 18 years;
  2. diagnosed with Pulmonary Arterial Hypertension (WHO) Category Group 1
  3. Patient is in stable clinical condition and
  4. the previous specific PH medication has been retained unchanged during the past 3 weeks
Other: PH patients with LenusPro pump
Observation/measurement of complications in PH patients with LenusPro pump in the frist six month after implantation of pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of numbers of predefined complications in longterm treatment with LenusPro medication pump
Time Frame: from implantation of pump (baseline) up to six month after implantation
Rate and type of predefined intraoperative complications (by implantation) as assessed by the implanting physician:
from implantation of pump (baseline) up to six month after implantation
Measurement of catheter (or pump) complications
Time Frame: from implantation of pump up to month six
Rate and type of predefined catheter (or pump) complications
from implantation of pump up to month six

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of numbers of predefined refill complications
Time Frame: from implanation of pump (baseline) up to six month after implantation
Refill complications, e.g. filling impossible because filling port cannot be found or fluoroscopy required to find filling port
from implanation of pump (baseline) up to six month after implantation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of quality of life (QoL)
Time Frame: from implantation of pump (baseline) up to six months after implantation
Patient reported outcome (Questionaire EQ-5D-5L)
from implantation of pump (baseline) up to six months after implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Investigators

  • Principal Investigator: Ralf Ewert, M.D., University Hospital of Greifswald

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

September 25, 2013

First Submitted That Met QC Criteria

November 3, 2013

First Posted (Estimate)

November 8, 2013

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 3, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPS-1
  • LPS-1-2013 (Other Identifier: University of Greifswald)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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