Implantable Intravascular Catheter for Pulmonary Arterial Hypertension
(DelIVery Trial)

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

DelIVery for PAH Clinical Research Specialist

Principal Investigator

Medtronic

Eligibility Criteria

This trial is for patients already enrolled in the DelIVery for PAH Study, who along with their physician believe that continuing to use the PIVoT system is beneficial. They must be willing to consent to ongoing participation.

Inclusion Criteria

Patient is willing to sign and date the Patient Informed Consent Form

Patient is currently enrolled in the DelIVery for PAH Study (G100017)

My doctor and I agree that using the PIVoT system is good for my health.

Treatment Details

Interventions

Model 10642 Implantable Intravascular Catheter (Implantable Device)

Trial OverviewThe study evaluates the safety of using Medtronic's Model 10642 Implantable Intravascular Catheter with SynchroMed II System to deliver Remodulin Injection for treating Pulmonary Arterial Hypertension.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: DelIVery for Pulmonary Arterial Hypertension Single ArmExperimental Treatment1 Intervention

All subjects were enrolled for implantation of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection.