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IDE-ALERTS Continued Access Study — ALERTS-CAS  

Acute Coronary Syndrome Clinical Trial

Official title:
ALERTS Continued Access Study- IDE G060259 Supplement

Clinical Trial Summary

This Continued Access IDE Study includes a subset of former ALERTS trial (NCT00781118) patients and provides performance data for a refined Guardian implantable medical device (AMSG3-E) with a new battery designed to extend device longevity.

Clinical Trial Description

This Continued Access IDE Study is a prospective, non-randomized, multi-center (up to 25 sites) study designed to provide performance assessment of a refined Guardian implantable medical device (AMSG3-E) through controlled access of a replacement Guardian System to a subset of former ALERTS patients while waiting for FDA approval of the AMSG3-E. The AMSG3-E contains a drop-in replacement battery designed to extend the life of the implant to potentially exceed the previous 3-years implant life. Eligible patients will include those that exited the ALERTS study and chose to leave the device and/or lead in place. Eligible patients must also continue to meet ALERTS inclusion criteria and not have developed any exclusion criteria since exiting the ALERTS study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04316481
Study type Interventional
Source Angel Medical Systems
Contact
Status Terminated
Phase N/A
Start date September 22, 2020
Completion date January 20, 2022
View Details
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