DelIVery for Pulmonary Arterial Hypertension (PAH) & Continued Support Study (DelIVery)

This is an interventional supportive care trial for Pulmonary Arterial Hypertension Read More

Inclusion Criteria:

• Patient is eighteen (18) years of age or older
• 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 Associated with PAH (APAH), with exceptions as noted in exclusion criteria
• Patient is receiving continuous infusion of Remodulin Injection therapy via intravenous delivery using an external drug delivery pump system. Patient has been at a stable Remodulin Injection dose (no change in dose) for at least four (4) weeks
• Patient's anticoagulation therapy can be managed to permit safe device implantation
• Patient has no history of pulmonary embolism since the initiation of subcutaneous or intravenous (IV) therapy for PAH

Exclusion Criteria:

• Patient is a woman who is pregnant, nursing, or of child bearing potential and is not on a reliable form of birth control
• Patient is enrolled, has participated within the last thirty (30) days, or is planning to participate, in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the Medtronic study manager that there is not a concern that co-enrollment could confound the results of this trial.
• Patient has been initiated on a new oral PAH therapy in the last two (2) months
• Patient has had a recent (within three (3) months) or otherwise unresolved infection requiring antibiotic treatment
• Patient is diagnosed with PAH associated with hemoglobinopathies (sickle cell anemia, thalassemia), human immunodeficiency virus (HIV), schistosomiasis, portal hypertension, pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis
• Patient is implanted with electrical stimulation medical device(s) anywhere in the body (e.g., cardiac pacemakers, implantable cardioverter defibrillators (ICDs), spinal cord stimulators). This includes implanted leads and electrodes or abandoned leads and electrodes from an explanted device
• Patient is diagnosed with chronic kidney disease (serum creatinine greater than 2.5 milligrams per deciliter) 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.
• Patient is a person for whom the implantable vascular catheter length of eighty (80) centimeters (cm) is excessively long or too short to be properly implanted
• Patient has an existing external catheter(s) that would remain in place after the pump implant
• Patient is a person for whom the implantable pump cannot be implanted two and a half (2.5) centimeters (cm) or less from the skin surface
• Patient is a person whose body size is not sufficient to accept implantable pump bulk and weight
• Patient is at increased susceptibility to systemic or soft tissue infections as determined by physician
• Patient is Functional Class IV (New York Heart Association (NYHA))