Implantable System for Remodulin Post-Approval Study

Medtronic Cardiac Rhythm and Heart Failure

Overview

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.

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

Conditions

Pulmonary Arterial Hypertension

Interventions

Implantable System for Remodulin (treprostinil)COMBINATION_PRODUCT

All patients will be implanted with the Implantable System for Remodulin (treprostinil).

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Catheter-related complications

Number of adverse events requiring invasive intervention that are related to the ISR catheter.

Time frame: Implant to 5 years post-implant

Pump failures

Number of adverse events requiring invasive intervention that are related to the ISR pump.

Time frame: Implant to 5 years post-implant

Data from ClinicalTrials.gov

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