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

Pulmonary Arterial Hypertension Clinical Trial

— DelIVery  

Official title:

DelIVery for Pulmonary Arterial Hypertension (PAH) Clinical Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01321073
• Other study ID #: PAH-D
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2011
• Est. completion date: December 2032

Study information

• Verified date: September 2023
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: December 2032
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	VA Greater Los Angeles Healthcare System	Los Angeles	California
United States	Aurora St. Lukes Medical Center	Milwaukee	Wisconsin
United States	AdventHealth Orlando	Orlando	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure	United Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (5)

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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