Implantable System for Remodulin Post-Approval Study
Withdrawn
- Conditions
- Pulmonary Arterial Hypertension
- Registration Number
- NCT03833323
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- 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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Catheter-related complications Implant to 5 years post-implant Number of adverse events requiring invasive intervention that are related to the ISR catheter.
Pump failures Implant to 5 years post-implant Number of adverse events requiring invasive intervention that are related to the ISR pump.
- Secondary Outcome Measures
Name Time Method