Status:
WITHDRAWN
Implantable System for Remodulin Post-Approval Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
United Therapeutics
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
22+ years
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, in...
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03833323
Start Date
August 1 2020
End Date
June 30 2021
Last Update
July 2 2021
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