DelIVery for Pulmonary Arterial Hypertension (PAH) & Continued Support Study

NAActive, not recruitingINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

June 30, 2013

Study Completion Date

December 31, 2032

Conditions
Pulmonary Arterial Hypertension
Interventions
DEVICE

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.

Trial Locations (8)

32803

AdventHealth Orlando, Orlando

35294

University of Alabama at Birmingham, Birmingham

53234

Aurora St. Lukes Medical Center, Milwaukee

55905

Mayo Clinic, Rochester

60637

University of Chicago Medical Center, Chicago

90073

VA Greater Los Angeles Healthcare System, Los Angeles

02115

Brigham & Women's Hospital, Boston

75390-7208

University of Texas Southwestern Medical Center, Dallas

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

United Therapeutics

INDUSTRY

lead

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY