Pulmonary Arterial HypertensionISR PASNCT03833323
Implantable System for Remodulin Post-Approval Study
An observational study of Pulmonary Arterial Hypertension, run by Medtronic Cardiac Rhythm and Heart Failure.
Trial summary
The purpose of the Implantable System for Remodulin (ISR) Post Approval Study (PAS) is to provide evaluation and periodic reporting of the safety and effectiveness of Medtronic market-released ISR, including the catheter and the pump. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Implantable System for Remodulin (treprostinil)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly implanted patients that are intended to receive an ISR.
Who may be able to join
- Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements.
- Subject is intended to receive an eligible ISR product.
- Subject is at least 22 years of age.
Who cannot join
- Subject is pregnant.
- Subject who is expected to be inaccessible for follow-up.
- Subject with exclusion criteria required by local law.
- Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness).
About this study
The purpose of the Implantable System for Remodulin (ISR) Post Approval Study (PAS) is to provide evaluation and periodic reporting of the safety and effectiveness of Medtronic market-released ISR, including the catheter and the pump.
Read the detailed description
The ISR PAS is an observational, prospective, non-randomized, multi-center study. It will enroll a minimum of 50 newly implanted patients at up to 10 US sites, observing and reporting catheter-related complications and pump failures through 5 years post implant.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Implantable System for Remodulin (treprostinil)
- Keywords
- PAH, Pulmonary Arterial Hypertension, Pulmonary Hypertension, Remodulin, treprostinil, DelIVery for PAH, Implantable Pump, Drug Pump, Intrathecal Catheter, Targeted Drug Delivery, Programmable Pump
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable System for Remodulin (treprostinil)Combination product
All patients will be implanted with the Implantable System for Remodulin (treprostinil).
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter-related complications
Number of adverse events requiring invasive intervention that are related to the ISR catheter.
Measured: Implant to 5 years post-implant
Pump failures
Number of adverse events requiring invasive intervention that are related to the ISR pump.
Measured: Implant to 5 years post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start1 Aug 2020 (estimated)
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: Implantable System for Remodulin not commercially approved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 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
- Robert Bourge, MD, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833323
- Sponsor's protocol ID
- ISR PAS
- Acronym
- ISR PAS
- Status last verified
- Jun 2021
- First submitted
- 5 Feb 2019
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantable System for Remodulin Post-Approval Study
- ClinicalTrials.gov ID
- NCT03833323
- Acronym / sponsor ID
- ISR PAS / ISR PAS
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- PAH, Pulmonary Arterial Hypertension, Pulmonary Hypertension, Remodulin, treprostinil, DelIVery for PAH, Implantable Pump, Drug Pump
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Implantable System for Remodulin not commercially approved.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- United Therapeutics
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
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 Implantable System for Remodulin (ISR) Post Approval Study (PAS) is to provide evaluation and periodic reporting of the safety and effectiveness of Medtronic market-released ISR, including the catheter and the pump.
Detailed description
The ISR PAS is an observational, prospective, non-randomized, multi-center study. It will enroll a minimum of 50 newly implanted patients at up to 10 US sites, observing and reporting catheter-related complications and pump failures through 5 years post implant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly implanted patients that are intended to receive an ISR.
Key inclusion criteria (3 listed)
- Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements.
- Subject is intended to receive an eligible ISR product.
- Subject is at least 22 years of age.
Key exclusion criteria (4 listed)
- Subject is pregnant.
- Subject who is expected to be inaccessible for follow-up.
- Subject with exclusion criteria required by local law.
- Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness).
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 |
|---|---|---|
| Implantable System for Remodulin (treprostinil)All patients will be implanted with the Implantable System for Remodulin (treprostinil). | Combination product | – |
Primary outcome
Catheter-related complications
Time frame: Implant to 5 years post-implant
Number of adverse events requiring invasive intervention that are related to the ISR catheter.
Pump failures
Time frame: Implant to 5 years post-implant
Number of adverse events requiring invasive intervention that are related to the ISR pump.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
Related trials for Pulmonary Arterial Hypertension
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
RecruitingPhase 2
Spironolactone for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
RecruitingPhase 1/2
A Study of HS235 for Treatment of Pulmonary Arterial Hypertension (PAH) in Adults
Pulmonary Arterial Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
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.
Robert Bourge, MD study chair
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Medtronic Cardiac Rhythm and Heart Failure.
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 4 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: withdrawn, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Catheter-related complications (time frame: Implant to 5 years post-implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2021.