Implantable pump for PAH drug passes safety check
NCT ID NCT01321073
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests an implanted catheter and pump system that delivers Remodulin, a drug for pulmonary arterial hypertension (PAH), directly into the bloodstream. The goal is to see if this device is safe for long-term use. The trial includes 64 patients who already use the system. The study is no longer seeking approval but continues to support those still implanted.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Remodulin (treprostinil) injection
- What this could lead to
- If successful, this could confirm a safer way to deliver PAH medication through an implanted pump, reducing infection risks.
- What could go wrong
- The trial is small (64 participants) and no longer pursuing approval. It only supports existing patients, so results may not lead to a new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
64 people
The number who actually took part.
- Started
-
Jun 2011
- Expected to finish
-
Dec 2032
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
AdventHealth Orlando
Orlando, Florida, 32803, United States
-
Aurora St. Lukes Medical Center
Milwaukee, Wisconsin, 53234, United States
-
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
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University of Chicago Medical Center
Chicago, Illinois, 60637, United States
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University of Texas Southwestern Medical Center
Dallas, Texas, 75390-7208, United States
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VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
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