Implantable System for Remodulin Post-Approval Study
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pulmonary Arterial Hypertension
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 22 years and 125 years
- Gender
- Both males and females
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.
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.
Tracking Information
- NCT #
- NCT03833323
- Collaborators
- United Therapeutics
- Investigators
- Study Chair: Robert Bourge, MD University of Alabama at Birmingham