Medtronic DelIVery for Pulmonary Arterial Hypertension (PAH)

Study ID
STU 112010-134

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Jacqueline Quivers
214-645-6489
jacqueline.quivers@utsouthwestern.edu

Principal Investigator
Sonja Bartolome

Summary

The DeliVery for PaH study is a multicenter, prospective, single arm, non-randomized open label study to evaluate the safety of the Model 10642 implantable intravascular Catheter for use in the treatment of PaH. The study population will include patients currently treated with the approved intravenous (iV) infusion route of delivery of Remodulin injection for PaH.

Participant Eligibility

Patients must meet these criteria to be eligible for the study:

* Patient is 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)

* 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 weeks

* Patient[Single Quote]s anticoagulation therapy can be managed to permit safe device implantation

* Patient has no history of pulmonary embolism since the initiation of subcutaneous or IV therapy for PAH