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NCT03833323 Clinical Trial

Implantable System for Remodulin Post-Approval Study

Pulmonary Arterial Hypertension Clinical Trial

— ISR PAS  

Official title:
Implantable System for Remodulin Post-Approval Study

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03833323
Other study ID # ISR PAS
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date June 30, 2021

Study information
Verified date June 2021
Source Medtronic Cardiac Rhythm and Heart Failure
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• Implantable System for Remodulin (treprostinil)
All patients will be implanted with the Implantable System for Remodulin (treprostinil).

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Medtronic Cardiac Rhythm and Heart Failure United Therapeutics

Outcome
Type Measure Description Time frame Safety issue
Primary Catheter-related complications Number of adverse events requiring invasive intervention that are related to the ISR catheter. Implant to 5 years post-implant
Primary Pump failures Number of adverse events requiring invasive intervention that are related to the ISR pump. Implant to 5 years post-implant
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