NCT04316481

IDE-ALERTS Continued Access Study

ALERTS Continued Access Study- IDE G060259 Supplement

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Angel Medical Systems · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DEVICE	AngelMed Guardian System	The AngelMed Guardian System detects potential ongoing ACS events, characterized by sustained ST segment changes, and alerts the patient to seek medical attention for those potential ACS events. The Guardian System is indicated as an adjunct to patient recognized symptoms.

Timeline

• Start date: 2020-09-22
• Primary completion: 2022-01-20
• Completion: 2022-01-20
• First posted: 2020-03-20
• Last updated: 2022-06-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study