DelIVery for Pulmonary Arterial Hypertension (PAH) & Continued Support Study (DelIVery)

DelIVery for Pulmonary Arterial Hypertension (PAH) Clinical Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Device: Model 10642 Implantable Intravascular Catheter

Detailed Description

Pulmonary arterial hypertension (PAH) is a severe, chronic syndrome affecting the small pulmonary arteries (blood vessels which carry blood from the heart to the lungs to pick up oxygen). At the time of the initiation of this study, no cure exists for this disease. Medtronic has developed a fully implantable, long term, intravenous infusion system, which has the potential to enhance patient convenience and ease of use, while reducing the opportunities for catheter-related infections and complication issues associated with currently used external delivery systems. The information gained from this study could provide evidence to support use on an implantable infusion system for the management of other disease states requiring chronic intravenous therapy. Additionally, information collected from this study may contribute to the design of new product(s)/therapy(ies) and/or instructions for use.

The purpose of this clinical study is to evaluate the safety profile of the Model 10642 Implantable Intravascular Catheter portion of the PAH Implantable Vasodilator Therapy (PIVoT) system. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration.

The Model 10642 Implantable Intravascular Catheter being used in this study is investigational, meaning it has not been approved by the FDA to be safe. The Model 10642 Catheter is different from other commercially available drug delivery catheters because the Model 10642 Catheter tube has a one-way valve designed to allow the medication to flow out but keep blood from flowing back into the catheter tube. The Model 10642 Catheter is reinforced to prevent kinking and crushing, which could interrupt the flow of medication.

Remodulin Injection is a Food and Drug Administration (FDA) approved drug for the intravenous and subcutaneous treatment of PAH.

The SynchroMed II Implantable Infusion System is approved by the FDA to deliver specific drugs in patients who have chronic pain, need management of severe spasticity, and for cancer treatment but has not been approved to deliver Remodulin Injection in patients with PAH.

There is also a Catheter Imaging Sub-Study that is being done to measure the shape change of the Model 10642 Implantable Intravascular Catheter during a given set of patient positions through the use of x-ray imaging. This data will help us develop more clinically realistic bench tests and simulations that better mimic the challenges experienced by an implanted catheter. This Catheter Imaging Sub-Study will be conducted at up to seven centers and will enroll up to forty patients that are currently enrolled in the DelIVery for PAH clinical study and are at least three months post-implant of their current catheter and pump.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Healthcare System
  • Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Texas
    • Dallas, Texas, United States, 75390-7208
      • University of Texas Southwestern Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53234
      • Aurora St. Lukes Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient is currently enrolled in the DelIVery for PAH Study (G100017)
• The physician and patient determine that continued use of the PIVoT system is medically advisable
• Patient is willing to sign and date the Patient Informed Consent Form

Exclusion Criteria:

- N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: DelIVery for Pulmonary Arterial Hypertension Single Arm; 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.

Device: Model 10642 Implantable Intravascular Catheter; This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration.; Other Names: Device: SynchroMed II Implantable Infusion System; Drug: Remodulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Catheter-related Complications Per 1000 Patient Days	A complication is an adverse event that required an invasive intervention. Complications related to the implanted catheter are counted. In addition, because pneumothoraxes are counted as part of the endpoint.	Implant to 2 years

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Collaborators: United Therapeutics
• Investigators: Study Chair: DelIVery for PAH Clinical Research Specialist, Medtronic

Publications and helpful links

General Publications

• Waxman AB, McElderry HT, Gomberg-Maitland M, Burke MC, Ross EL, Bersohn MM, Pangarkar SS, Tarver JH, Zwicke DL, Feldman JP, Chakinala MM, Frantz RP, Thompson GB, Torres F, Rauck RL, Clagg K, Durst L, Li P, Morris M, Southall KL, Peterson L, Bourge RC. Totally Implantable IV Treprostinil Therapy in Pulmonary Hypertension Assessment of the Implantation Procedure. Chest. 2017 Dec;152(6):1128-1134. doi: 10.1016/j.chest.2017.04.188. Epub 2017 Jun 3.
• Gomberg-Maitland M, Bourge RC, Shapiro SM, Tarver JH 3rd, Zwicke DL, Feldman JP, Chakinala MM, Frantz RP, Torres F, Bag R, Murphy JA, Lautenbach AA, Morris M, Peterson L, Waxman AB. Long-term results of the DelIVery for Pulmonary Arterial Hypertension trial. Pulm Circ. 2019 Nov 5;9(4):2045894019878615. doi: 10.1177/2045894019878615. eCollection 2019 Oct-Dec.
• Shapiro S, Bourge RC, Pozella P, Harris DF, Borg EH, Nelsen AC. Implantable system for treprostinil: a real-world patient experience study. Pulm Circ. 2020 Apr 22;10(2):2045894020907881. doi: 10.1177/2045894020907881. eCollection 2020 Apr-Jun.
• Feldman JP, Gomberg-Maitland M, Shapiro SM, Lautenbach AA, Morris M, Murphy JA, Waxman AB, Bourge RC. Implantable system for treprostinil and lung transplantation: case series from delivery for pulmonary arterial hypertension study. Pulm Circ. 2021 Mar 2;11(1):2045894021999290. doi: 10.1177/2045894021999290. eCollection 2021 Jan-Mar.
• Bourge RC, Waxman AB, Gomberg-Maitland M, Shapiro SM, Tarver JH 3rd, Zwicke DL, Feldman JP, Chakinala MM, Frantz RP, Torres F, Cerkvenik J, Morris M, Thalin M, Peterson L, Rubin LJ. Treprostinil Administered to Treat Pulmonary Arterial Hypertension Using a Fully Implantable Programmable Intravascular Delivery System: Results of the DelIVery for PAH Trial. Chest. 2016 Jul;150(1):27-34. doi: 10.1016/j.chest.2015.11.005. Epub 2016 Jan 13.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: March 21, 2011
• First Submitted That Met QC Criteria: March 21, 2011
• First Posted (Estimated): March 23, 2011

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Antihypertensive Agents; Treprostinil
• Other Study ID Numbers: PAH-D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO