CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 64 enrolled
Drug / intervention
Model 10642 Implantable Intravascular Catheterdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT01321073N/AActive
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DelIVery for Pulmonary Arterial Hypertension (PAH) Clinical Study

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Mar 23, 2011·Updated Jan 26, 2026

In Brief

A clinical study evaluating Model 10642 Implantable Intravascular Catheter for Pulmonary Arterial Hypertension. Active but no longer recruiting, targeting 64 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesUnited States
CollaboratorsUnited Therapeutics

Timeline

N/AActive
20112012201320142015201620172018201920202021202220232024202520262027202820292030203120322033
First PostedMar 23, 2011
Enrollment StartJun 1, 2011
Primary CompletionJun 1, 2013
Study CompletionDec 1, 2032
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.3 years ago

Interventions

Model 10642 Implantable Intravascular Catheterdevice

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.