Implantable System for Remodulin Post-Approval Study

NCT03833323 | Withdrawn FDA Drug FDA Device

• 1 other identifier: ISR PAS
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pulmonary Arterial Hypertension

Keywords

PAH; Pulmonary Arterial Hypertension; Pulmonary Hypertension; Remodulin; treprostinil; DelIVery for PAH; Implantable Pump; Drug Pump; Intrathecal Catheter; Targeted Drug Delivery; Programmable Pump

Outcome Measures

Primary Outcomes (2)

• Catheter-related complications

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

  Implant to 5 years post-implant

• Pump failures

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

  Implant to 5 years post-implant

Interventions

Implantable System for Remodulin (treprostinil) COMBINATION_PRODUCT

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

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly implanted patients that are intended to receive an ISR.

You may qualify if:

• 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.

You may not qualify if:

• Subject is pregnant.
• Subject who is expected to be inaccessible for follow-up.
• 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).

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• United Therapeutics: collaborator

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Robert Bourge, MD

  University of Alabama at Birmingham

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 7, 2019
• Study Start: August 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 2, 2021

Record last verified: 2021-06