MedTrace Logo

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

NCT01321073 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-01-26

Study results available
· View outcomes & findings →

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.

Conditions

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.

Sponsors & Collaborators

  • United Therapeutics

    collaborator INDUSTRY

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • DelIVery for PAH Clinical Research Specialist · Medtronic

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-06-30
Completion
2032-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01321073 on ClinicalTrials.gov