A Study of an Implantable System for Remodulin Post Approval

Overview

About this study

The purposes of this study is to estimate the freedom from catheter-related complications through 5 years post-implant and to estimate the freedom from ISR pump failures through 5 years post- implant.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert Frantz, M.D.

Open for enrollment

Contact information:

Pulmonary Clinical Research Unit

(800) 753-1606

PCRUE18@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available