IDE-ALERTS Continued Access Study

ALERTS Continued Access Study- IDE G060259 Supplement

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04316481

Acronym

ALERTS-CAS

Enrollment

Registered

2020-03-20

Start date

2020-09-22

Completion date

2022-01-20

Last updated

2022-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Brief 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.

Interventions

DEVICEAngelMed 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Continued Access

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

(all must be true): * Subject previously participated in the ALERTS study and currently has either a Guardian System IMD plus IS-1 lead or IS-1 lead still in place and hasn't developed

Exclusion criteria

. * Subject (men or women) is at least 21 years of age. * Women of childbearing age must have a negative pregnancy test or confirmation of one of the following: 1. Post-menopause or amenorrhoeic during the past year 2. Surgical sterilization 3. Use of effective contraceptive method

Design outcomes

Primary

Measure	Time frame	Description
Rate of Serious Adverse Events (SAE)	5 years	Annual rate of SAEs related to the device or procedure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026