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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
No Placebo-Only Group

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.
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.
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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of Catheter-related Complications Per 1000 Patient Days

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

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Who is running the clinical trial?

Medtronic Cardiac Rhythm and Heart FailureLead Sponsor
205 Previous Clinical Trials
136,755 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
United TherapeuticsIndustry Sponsor
110 Previous Clinical Trials
14,462 Total Patients Enrolled
59 Trials studying Pulmonary Arterial Hypertension
8,221 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
~4 spots leftby Dec 2025
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