500
Participants
Start Date
September 7, 2022
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2026
PMA P150009 AngelMed Guardian® System
"The AngelMed Guardian® System is an implantable cardiac monitor with patient alerting capability and an additional external alarm device. The Guardian® System is indicated for use in patients who have had prior ACS events and who remain at high risk for recurrent ACS events. The Guardian® System is indicated as an adjunct to patient recognized symptoms. The 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.~A Guardian® System alert is a more accurate predictor of ACS events when compared to patient recognized symptoms alone and demonstrates a reduced rate over time of patient presentations without ACS events (false positives) when compared to patient recognized symptoms alone. In the absence of symptoms, the Guardian® System may identify asymptomatic ACS events and prompt the patient to seek medical attention."
RECRUITING
Northside Hospital Cardiovascular Institute, Atlanta
RECRUITING
Daytona Heart Group, Daytona Beach
SUSPENDED
LEJ Medical, LLC, New Smyrna Beach
RECRUITING
Institute for Cardiovascular Research Studies, Inc., Miami
RECRUITING
Florida Heart Rhythm Specialists, Fort Lauderdale
RECRUITING
Clermont Ambulatory Surgical Center, Clermont
ACTIVE_NOT_RECRUITING
Corewell Health, Grand Rapids
RECRUITING
Heart Clinic of Hammond, Hammond
ACTIVE_NOT_RECRUITING
Cardiovascular Associate Research, Covington
ACTIVE_NOT_RECRUITING
North Shore Heart and Vascular, Mandeville
RECRUITING
South Oklahoma Heart Research, Oklahoma City
RECRUITING
Medical City Hospital Forth Worth, Fort Worth
RECRUITING
Texan Cardiovascular Institute, El Paso
ACTIVE_NOT_RECRUITING
Southwest Cardiovascular Associates, Mesa
RECRUITING
Phoenix Heart, Glendale
RECRUITING
Arizona Heart & Vascular Clinic, Glendale
RECRUITING
East Los Angeles Cardiology, Los Angeles
ACTIVE_NOT_RECRUITING
Orange County Heart and Research Institute, Orange
Lead Sponsor
Angel Medical Systems
INDUSTRY