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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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03833323
Study type Observational
Source Medtronic Cardiac Rhythm and Heart Failure
Contact Andrea Schminke
Phone 763-514-2623
Email andrea.n.schminke@medtronic.com
Status Not yet recruiting
Phase
Start date March 15, 2019
Completion date March 2, 2025

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