Implantable Intravascular Catheter for Pulmonary Arterial Hypertension

(DelIVery Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a special implantable catheter system designed for people with pulmonary arterial hypertension, a type of high blood pressure affecting the lungs. The Model 10642 Implantable Intravascular Catheter works with an infusion system to deliver Remodulin, a medication that helps manage this condition. Participants must already be part of the ongoing study and, along with their doctor, believe that continuing with the implantable system benefits them. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance treatment options for pulmonary arterial hypertension.

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.

What prior data suggests that this catheter is safe for pulmonary arterial hypertension?

Research has shown that the Model 10642 Implantable Intravascular Catheter, used with the SynchroMed II system, has been tested for safety in delivering Remodulin. Studies have found that this setup is generally well-tolerated. The main concern has been whether the catheter causes any problems, but reports indicate that any issues related to the catheter remain within expected safety limits.

Although plans to further develop and sell this system have stopped, those already using it have not experienced major safety problems. Remodulin, the medication being delivered, is already approved for treating pulmonary arterial hypertension (high blood pressure in the lungs), which provides some reassurance about its safety. However, discussing any specific concerns with a healthcare provider before joining a trial might be helpful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Model 10642 Implantable Intravascular Catheter for pulmonary arterial hypertension because it offers a new delivery method. Unlike standard treatments that are often taken orally or through subcutaneous injections, this catheter is implanted and works with the SynchroMed II system to deliver medication directly into the bloodstream. This approach could ensure more consistent drug levels and potentially improve patient outcomes by reducing the peaks and troughs associated with other delivery methods.

What evidence suggests that this catheter is effective for pulmonary arterial hypertension?

Research has shown that the Model 10642 Implantable Intravascular Catheter is safe when used with the Medtronic SynchroMed II system. Participants in this trial will receive this setup to deliver Remodulin (treprostinil), a medication that manages symptoms of pulmonary arterial hypertension, a type of high blood pressure in the lungs. Studies focused on safety have demonstrated a low rate of complications related to the catheter. While the focus has been on safety, Remodulin is already known to effectively treat pulmonary arterial hypertension. The catheter system aims to provide a consistent and effective method for delivering this treatment. ^{1 2 3 5 6}

Who Is on the Research Team?

DelIVery for PAH Clinical Research Specialist

Principal Investigator

Medtronic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6831973/

Long-term results of the DelIVery for Pulmonary Arterial ... The DelIVery for Pulmonary Arterial Hypertension clinical trial was a multi-center, prospective, single arm, Investigational Device Exemption study

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01321073

DelIVery for Pulmonary Arterial Hypertension (PAH) & ... The purpose of this clinical study is to evaluate the safety profile of the Model 10642 Implantable Intravascular Catheter portion of the PAH Implantable ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf14/P140032B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The objective was to demonstrate that the Model 10642. Implantable Intravascular Catheter is safe when used with the Medtronic SynchroMed II.

4. withpower.com withpower.com/trial/phase-familial-primary-pulmonary-hypertension-5-2011-a6955

Implantable Intravascular Catheter for Pulmonary Arterial ... What data supports the effectiveness of the treatment Model 10642 Implantable Intravascular Catheter for pulmonary arterial hypertension? The research ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0012369215001609

Treprostinil Administered to Treat Pulmonary Arterial ... The primary end point was the rate of catheter-related complications using the new model 10642 catheter compared with a predefined objective performance ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2018/208276Orig1s000StatR.pdf

Statstical Review(s) - accessdata.fda.gov The purpose of the trial is to evaluate the safety profile of the. Model 10642 Implantable Intravascular Catheter, a component of the PAH Implantable.