Angel Medical Systems ALERTS Study - Enrollment

After a successful Phase One study in the US, the AngelMed Guardian System is presently being tested in the ALERTS pivotal study.   The system is currently available for investigational use only in the US.

AngelMed is currently signing on clinical research sites and enrolling patients in the ALERTS study.

Patient Exclusion Criteria

The physician at the clinical trial site will perform a series of screening tests and medically evaluate candidates for eligibility in the ALERTS trial prior to enrollment. These exclusions include:

1. A permanent pacemaker or ICD is already in place or the patient is indicated for ICD or pacemaker implantation based on the guidelines published by the American College of Cardiology as Class I and IIa recommendations. Class IIb recommendations are at the investigator’s discretion.
2. Subject has previous participation in the DETECT Study, current participation or previous participation in another drug or device study in the past 30 days that conflicts with this study as determined by the study sponsor.

Potential Risks of Participation in the Clinical Study

Clinical trials involve risks and there may be side effects or adverse reactions to the device that may be unforeseeable.  Implantation of the AngelMed Guardian system requires surgery and implantation of a lead into the heart. As with any type of surgery there are potential risks involved.

All potential study participants will be given an informed consent form that describes all known risks.  As with any new medical device, there may be other risks that are currently unknown.

Prior to participation in this or any clinical study, it is important to discuss the clinical trial procedures, risks, and potential benefits of any procedure or operation in more detail with the physician at the clinical trial site.

How to participate?

Clinical research sites or individuals who desire more information about the ALERTS trial can contact Kristi Kotenberg at (612) 234-8471 or click here to fill out an information request form.

For all media inquiries, contact Jonathan Harwood, (732) 542-3111, jharwood@angel-med.com

For clinical sites already enrolled in the Alerts study, AngelMed Field Engineers can click here to upload trial data. A login and password are required.