Clinical Trial

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

Study acronym: DelIVery
Active, Not Recruiting
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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.
Protocol Amendment History 31 amendments
This ClinicalTrials.gov record has been amended 31 times since 2011-03-21; most recent amendment 2026-01-07.
Status change: Recruiting → Active, Not Recruiting 2012-12-06
Status change: Suspended → Recruiting 2012-05-30
Status change: Recruiting → Suspended 2012-03-27
Status change: Not Yet Recruiting → Recruiting 2011-06-16
Trial Details
NCT Number NCT01321073
Lead Sponsor Medtronic Cardiac Rhythm and Heart Failure
Collaborators: United Therapeutics
Conditions Pulmonary Arterial Hypertension
Enrollment 64 participants
Start Date 2011-06
Primary Completion 2013-06 (estimated)
Study Completion 2032-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-26