Pulmonary Arterial HypertensionDelIVeryNCT01321073
DelIVery for Pulmonary Arterial Hypertension (PAH) & Continued Support Study
A study testing Model 10642 Implantable Intravascular Catheter in people with Pulmonary Arterial Hypertension, run by Medtronic Cardiac Rhythm and Heart Failure at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Model 10642 Implantable Intravascular Catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2011to Dec 2032
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Brigham & Women's Hospital
Boston, Massachusetts, 02115
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-7208
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Aurora St. Lukes Medical Center
Milwaukee, Wisconsin, 53234
AdventHealth Orlando
Orlando, Florida, 32803
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Model 10642 Implantable Intravascular Catheter
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model 10642 Implantable Intravascular CatheterDevice
Also called Device: SynchroMed II Implantable Infusion System, Drug: Remodulin
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Model 10642 Implantable Intravascular Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Implant to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United Therapeutics
- Responsible party
- Sponsor
- Investigators
- DelIVery for PAH Clinical Research Specialist, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321073
- Sponsor's protocol ID
- PAH-D
- Acronym
- DelIVery
- Status last verified
- Dec 2025
- First submitted
- 21 Mar 2011
- Last updated
- 26 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 28583617Gomberg-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.
PubMed 31723407Shapiro 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.
PubMed 32363029Feldman 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.
PubMed 33738097Bourge 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.
PubMed 27396777
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DelIVery for Pulmonary Arterial Hypertension (PAH) Clinical Study
- ClinicalTrials.gov ID
- NCT01321073
- Acronym / sponsor ID
- DelIVery / PAH-D
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- United Therapeutics
- Study start
- Jun 2011 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2032 (estimated)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Posted 4 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| DelIVery for Pulmonary Arterial Hypertension Single Arm | Experimental | Device: Model 10642 Implantable Intravascular CatheterAll 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Model 10642 Implantable Intravascular CatheterAlso: Device: SynchroMed II Implantable Infusion System, Drug: RemodulinThis 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. | Device | DelIVery for Pulmonary Arterial Hypertension Single Arm |
Primary outcome
Rate of Catheter-related Complications Per 1000 Patient Days
Time frame: Implant to 2 years
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28583617Waxman 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.
- Background: PubMed 31723407Gomberg-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.
- Background: PubMed 32363029Shapiro 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.
- Background: PubMed 33738097Feldman 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.
- Results publication: PubMed 27396777Bourge 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DelIVery for PAH Clinical Research Specialist study chair
Medtronic
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Model 10642 Implantable Intravascular Catheter in people with Pulmonary Arterial Hypertension, run by Medtronic Cardiac Rhythm and Heart Failure at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Catheter-related Complications Per 1000 Patient Days (time frame: Implant to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01321073, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.