Implantable Intravascular Catheter for Pulmonary Arterial Hypertension

(DelIVery Trial)

Recruiting at 9 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

64 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on supporting patients already using a specific system, so it's best to discuss your medications with the trial team.

How does the Implantable Intravascular Catheter treatment for pulmonary arterial hypertension differ from other treatments?

This treatment is unique because it uses a fully implantable system to deliver medication directly into the bloodstream, reducing complications associated with external pumps and improving patients' quality of life and independence. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Model 10642 Implantable Intravascular Catheter for pulmonary arterial hypertension?

The research mentions the use of an implantable hemodynamic monitor to assess treatment response in pulmonary arterial hypertension patients, suggesting that similar implantable devices can be useful in managing this condition. ^{3 6 7 8 9}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Treatment

Participants are implanted with the Model 10642 Implantable Intravascular Catheter and begin treatment with Remodulin Injection

3 months

Regular visits for monitoring and adjustment

Catheter Imaging Sub-Study

Participants undergo x-ray imaging to measure shape change of the catheter during different patient positions

Ongoing

Conducted at up to seven centers

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Treatment Details

Interventions

• Model 10642 Implantable Intravascular Catheter

Trial Overview 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.

Participant Groups

Group I: DelIVery for Pulmonary Arterial Hypertension Single Arm Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Medtronic Cardiac Rhythm and Heart Failure

Lead Sponsor

Trials

206

Recruited

137,000+

Geoff Martha

Medtronic Cardiac Rhythm and Heart Failure

Chief Executive Officer since 2020

MBA from University of Minnesota

Dr. Kweli Thompson

Medtronic Cardiac Rhythm and Heart Failure

Chief Medical Officer since 2022

MD from Harvard Medical School

United Therapeutics

Industry Sponsor

Trials

112

Recruited

14,500+

Dr. Martine Rothblatt

United Therapeutics

Chief Executive Officer since 1996

PhD in Medical Ethics from the Royal London College of Medicine and Dentistry, JD and MBA from UCLA

Dr. Michael Benkowitz

United Therapeutics

Chief Medical Officer since 2023

MD from Harvard Medical School

References

1. England pubmed.ncbi.nlm.nih.gov

Pulmonary artery ablation to treat pulmonary arterial hypertension: a case report. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Transplantation of autologous endothelial progenitor cells may be beneficial in patients with idiopathic pulmonary arterial hypertension: a pilot randomized controlled trial. [2007]

3. Switzerland pubmed.ncbi.nlm.nih.gov

[Diagnosis and medical treatment of pulmonary arterial hypertension]. [2010]

4. United States pubmed.ncbi.nlm.nih.gov

Continuous hemodynamic monitoring in patients with pulmonary arterial hypertension. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Pulmonary artery denervation to treat pulmonary arterial hypertension: the single-center, prospective, first-in-man PADN-1 study (first-in-man pulmonary artery denervation for treatment of pulmonary artery hypertension). [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Long-term results of the DelIVery for Pulmonary Arterial Hypertension trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Totally Implantable IV Treprostinil Therapy in Pulmonary Hypertension Assessment of the Implantation Procedure. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Implantable system for treprostinil: a real-world patient experience study. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Preserved right ventricular integrity in a new telemetric rat model of severe pulmonary hypertension. [2020]