Implantable System for Remodulin Post-Approval Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 July 2021
• Main ID: NCT03833323
• Date of registration: 05/02/2019
• Prospective Registration: Yes
• Primary sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Public title: Implantable System for Remodulin Post-Approval Study ISR PAS
• Scientific title: Implantable System for Remodulin Post-Approval Study
• Date of first enrolment: August 1, 2020
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03833323
• Study type: Observational

Contacts

• Name: Robert Bourge, MD
• Affiliation: University of Alabama at Birmingham

Key inclusion & exclusion criteria

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).



Age minimum: 22 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Combination Product: Implantable System for Remodulin (treprostinil)

Primary Outcome(s)

Pump failures [Time Frame: Implant to 5 years post-implant]

Catheter-related complications [Time Frame: Implant to 5 years post-implant]

Secondary ID(s)

ISR PAS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

United Therapeutics