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

June 30, 2021 updated by: Medtronic Cardiac Rhythm and Heart Failure
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newly implanted patients that are intended to receive an ISR.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

United Therapeutics

Investigators

  • Study Chair: Robert Bourge, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

February 5, 2019

First Submitted That Met QC Criteria

February 5, 2019

First Posted (Actual)

February 7, 2019

Study Record Updates

Last Update Posted (Actual)

July 2, 2021

Last Update Submitted That Met QC Criteria

June 30, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISR PAS

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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