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Implantable System for Remodulin Post-Approval Study (ISR PAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03833323
Recruitment Status : Withdrawn (Implantable System for Remodulin not commercially approved.)
First Posted : February 7, 2019
Last Update Posted : July 2, 2021
Sponsor:
Collaborator:
United Therapeutics
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Combination Product: Implantable System for Remodulin (treprostinil)

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
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implantable System for Remodulin Post-Approval Study
Estimated Study Start Date : August 1, 2020
Actual Primary Completion Date : June 30, 2021
Actual Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Combination Product: Implantable System for Remodulin (treprostinil)
    All patients will be implanted with the Implantable System for Remodulin (treprostinil).

Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Pump failures [ Time Frame: Implant to 5 years post-implant ]
    Number of adverse events requiring invasive intervention that are related to the ISR pump.


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly implanted patients that are intended to receive an ISR.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833323


Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
United Therapeutics
Investigators
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Study Chair: Robert Bourge, MD University of Alabama at Birmingham
More Information
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT03833323    
Other Study ID Numbers: ISR PAS
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
PAH
Pulmonary Arterial Hypertension
Pulmonary Hypertension
Remodulin
treprostinil
DelIVery for PAH
 Implantable Pump
Drug Pump
Intrathecal Catheter
Targeted Drug Delivery
Programmable Pump
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
 Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents