DelIVery for Pulmonary Arterial Hypertension (PAH) & Continued Support Study
Running, not enrolling · Not applicable
Conditions studied: Pulmonary Arterial Hypertension
In brief
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.
Key facts
- Study ID
- NCT01321073
- Run by
- Medtronic Cardiac Rhythm and Heart Failure
- People needed
- 64
- Starts
- 2011-06-01
- Expected to finish
- 2032-12-01
- Last updated by the study team
- 2026-01-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient is currently enrolled in the DelIVery for PAH Study (G100017)
- The physician and patient determine that continued use of the PIVoT system is medically advisable
- Patient is willing to sign and date the Patient Informed Consent Form
You may not qualify if…
- N/A
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
- AdventHealth Orlando — Orlando, Florida, United States
- University of Chicago Medical Center — Chicago, Illinois, United States
- Brigham & Women's Hospital — Boston, Massachusetts, United States
- Mayo Clinic — Rochester, Minnesota, United States
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
- Aurora St. Lukes Medical Center — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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