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

Medtronic

Status: Withdrawn

Conditions: Pulmonary Arterial Hypertension

Treatments: Combination Product: Implantable System for Remodulin (treprostinil)

Study type: Observational

Funder types: Industry

Identifiers

NCT03833323

ISR PAS

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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).