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DelIVery for Pulmonary Arterial Hypertension (PAH) & Continued Support Study
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Summary
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.
Official title: DelIVery for Pulmonary Arterial Hypertension (PAH) Clinical Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2011-06
Completion Date
2032-12
Last Updated
2026-01-26
Healthy Volunteers
No
Conditions
Interventions
Model 10642 Implantable Intravascular Catheter
This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration.
Locations (8)
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