DelIVery for Pulmonary Arterial Hypertension (PAH) & Continued Support Study
Active, not recruiting · Not applicable · NCT01321073
Conditions: Pulmonary Arterial Hypertension
At a glance
- Research payments reported, 2025
- $22,017
- U.S. investigators named
- 0
- Sites paid
- 0
- Planned or actual enrollment
- 64
About the trial
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure (with United Therapeutics)
- Tested
- Model 10642 Implantable Intravascular Catheter (device)
- Dates
- Started 2011-06; completion 2032-12
- Results posted
- Yes
The purpose of the DelIVery for PAH clinical study is to evaluate the safety of the Medtronic Model 10642 Implantable Intravascular Catheter when used with the Medtronic SynchroMed® II Implantable Infusion System to deliver Remodulin® (treprostinil) Injection. As of June 2021, PMA approval of the Implantable System for Remodulin (ISR) is no longer being pursued and development and commercialization efforts have been halted. The approximately 30 subjects still implanted with the PIVoT system require a pathway for continued support. This protocol is amended and is designed to allow such ongoing support.
From ClinicalTrials.gov, last updated 2026-01-26. Full record, eligibility and contacts (opens in a new tab)
Industry funding
United Therapeutics Corporation reported $22,017 in research payments for this study in 2025 (3 payments).
Products named: Remodulin
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
Sites paid to run it
- $22,017
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.