Pulmonary Arterial Hypertension
Conditions
Keywords
PAH, Pulmonary Arterial Hypertension, Pulmonary Hypertension, Remodulin, treprostinil, DelIVery for PAH, Implantable Pump, Drug Pump, Intrathecal Catheter, Targeted Drug Delivery, Programmable Pump
Brief summary
The purpose of the Implantable System for Remodulin (ISR) Post Approval Study (PAS) is to provide evaluation and periodic reporting of the safety and effectiveness of Medtronic market-released ISR, including the catheter and the pump.
Detailed description
The ISR PAS is an observational, prospective, non-randomized, multi-center study. It will enroll a minimum of 50 newly implanted patients at up to 10 US sites, observing and reporting catheter-related complications and pump failures through 5 years post implant.
Interventions
COMBINATION_PRODUCTImplantable System for Remodulin (treprostinil)
All patients will be implanted with the Implantable System for Remodulin (treprostinil).
Sponsors
United Therapeutics
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements. * Subject is intended to receive an eligible ISR product. * Subject is at least 22 years of age.
Exclusion criteria
* Subject is pregnant. * Subject who is expected to be inaccessible for follow-up. * Subject with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Catheter-related complications | Implant to 5 years post-implant | Number of adverse events requiring invasive intervention that are related to the ISR catheter. |
| Pump failures | Implant to 5 years post-implant | Number of adverse events requiring invasive intervention that are related to the ISR pump. |
Outcome results
None listed