Trials / Withdrawn
WithdrawnNCT03833323
Implantable System for Remodulin Post-Approval Study
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Implantable System for Remodulin (treprostinil) | All patients will be implanted with the Implantable System for Remodulin (treprostinil). |
Timeline
- Start date
- 2020-08-01
- Primary completion
- 2021-06-30
- Completion
- 2021-06-30
- First posted
- 2019-02-07
- Last updated
- 2021-07-02
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03833323. Inclusion in this directory is not an endorsement.