Ignite Creation Date:
2024-05-06 @ 12:44 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03833323
Status:
WITHDRAWN
Last Update Posted:
2021-07-02
First Post:
2019-02-05
Brief Title:
Implantable System for Remodulin Post-Approval Study
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
Implantable System for Remodulin Post-Approval Study
Status:
WITHDRAWN
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Implantable System for Remodulin not commercially approved
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISR PAS
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None