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

NCT01321073 | Active Not Recruiting Results DMC

• 1 other identifier: PAH-D
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

DelIVery for Pulmonary Arterial Hypertension Single Arm

EXPERIMENTAL

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

Interventions

Model 10642 Implantable Intravascular Catheter DEVICE

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.

Also known as: Device: SynchroMed II Implantable Infusion System, Drug: Remodulin

DelIVery for Pulmonary Arterial Hypertension Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- N/A

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• United Therapeutics: collaborator

Study Sites (8)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-7208, United States

Location

Aurora St. Lukes Medical Center

Milwaukee, Wisconsin, 53234, United States

Location

Related Publications (5)

• 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.

  PMID: 28583617 BACKGROUND

• 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.

  PMID: 31723407 BACKGROUND

• 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.

  PMID: 32363029 BACKGROUND

• 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.

  PMID: 33738097 BACKGROUND

• 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.

  PMID: 27396777 RESULT

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Results are through June, 2013 when 22,000 patient days of implant had been accumulated. This was the pre-specified primary analysis time for the study. The study continued past this point.

Results Point of Contact

• Title: Robert Bourge, M.D., Professor of Medicine, Radiology, and Surgery
• Organization: The University of Alabama at Birmingham

bbourge@uab.edu

(205)934-7400

Study Officials

• DelIVery for PAH Clinical Research Specialist

  Medtronic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is observational and intended to provide ongoing support for the approximately 20 remaining subjects enrolled in the DelIVery for PAH Study including support of pump refills and system replacements. The study is expected to continue at the eight (8) remaining centers located in the United States that have current DelIVery for PAH study subjects enrolled.

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 23, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion (Estimated): December 1, 2032
• Last Updated: January 26, 2026
• Results First Posted: May 4, 2018

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)