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Implantable Device

Implantable Intravascular Catheter for Pulmonary Arterial Hypertension (DelIVery Trial)

N/A
Waitlist Available
Research Sponsored by Medtronic Cardiac Rhythm and Heart Failure
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up implant to 2 years
Awards & highlights

DelIVery Trial Summary

This trial is no longer recruiting participants as of June 2021.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects may include issues related to catheter placement such as infection or blockage, and those associated with Remodulin like headache, diarrhea, jaw pain, nausea or rash.

DelIVery Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~implant to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and implant to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Catheter-related Complications Per 1000 Patient Days

DelIVery Trial Design

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.

Find a Location

Who is running the clinical trial?

Medtronic Cardiac Rhythm and Heart FailureLead Sponsor
198 Previous Clinical Trials
128,866 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
United TherapeuticsIndustry Sponsor
107 Previous Clinical Trials
13,323 Total Patients Enrolled
58 Trials studying Pulmonary Arterial Hypertension
8,165 Patients Enrolled for Pulmonary Arterial Hypertension
DelIVery for PAH Clinical Research SpecialistStudy ChairMedtronic

Media Library

Model 10642 Implantable Intravascular Catheter (Implantable Device) Clinical Trial Eligibility Overview. Trial Name: NCT01321073 — N/A
Pulmonary Arterial Hypertension Research Study Groups: DelIVery for Pulmonary Arterial Hypertension Single Arm
Pulmonary Arterial Hypertension Clinical Trial 2023: Model 10642 Implantable Intravascular Catheter Highlights & Side Effects. Trial Name: NCT01321073 — N/A
Model 10642 Implantable Intravascular Catheter (Implantable Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01321073 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
ChestJournal
Treprostinil Administered to Treat Pulmonary Arterial Hypertension Using a Fully Implantable Programmable Intravascular Delivery System
Bourge, Robert C., Aaron B. Waxman, Mardi Gomberg-Maitland, Shelley M. Shapiro, James H. Tarver III, Dianne L. Zwicke, Jeremy P. Feldman, et al.. 2016. “Treprostinil Administered to Treat Pulmonary Arterial Hypertension Using a Fully Implantable Programmable Intravascular Delivery System”. Chest. Elsevier BV. doi:10.1016/j.chest.2015.11.005.
ChestJournal
Totally Implantable IV Treprostinil Therapy in Pulmonary Hypertension Assessment of the Implantation Procedure
Waxman, Aaron B., Hugh T. McElderry, Mardi Gomberg-Maitland, Martin C. Burke, Edgar L. Ross, Malcolm M. Bersohn, Sanjog S. Pangarkar, et al.. 2017. “Totally Implantable IV Treprostinil Therapy in Pulmonary Hypertension Assessment of the Implantation Procedure”. Chest. Elsevier BV. doi:10.1016/j.chest.2017.04.188.
Pulmonary CirculationJournal
Implantable System for Treprostinil and Lung Transplantation: Case Series from Delivery for Pulmonary Arterial Hypertension Study
Feldman, Jeremy P., Mardi Gomberg‐Maitland, Shelley M. Shapiro, Amy A. Lautenbach, Marty Morris, Jeff A. Murphy, Aaron B. Waxman, and Robert C. Bourge. 2021. “Implantable System for Treprostinil and Lung Transplantation: Case Series from Delivery for Pulmonary Arterial Hypertension Study”. Pulmonary Circulation. Wiley. doi:10.1177/2045894021999290.
ChestJournal
Totally Implantable IV Treprostinil Therapy in Pulmonary Hypertension Assessment of the Implantation Procedure
Waxman, Aaron B., Hugh T. McElderry, Mardi Gomberg-Maitland, Martin C. Burke, Edgar L. Ross, Malcolm M. Bersohn, Sanjog S. Pangarkar, et al.. 2017. “Totally Implantable IV Treprostinil Therapy in Pulmonary Hypertension Assessment of the Implantation Procedure”. Chest. Elsevier BV. doi:10.1016/j.chest.2017.04.188.
All > Pulmonary Arterial Hypertension > Pulmonary Hypertension
~5 spots leftby Apr 2025
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