AngelMed Guardian® System PMA Post Approval Study
Start Date
9/7/2022
Completion Date
12/1/2026
Summary
500 Patients (minimum) will be enrolled following commercial implant. Will be treated by their physicians using the standard of care. Standard of care for the Guardian includes an in-office initial programming visit 7-14 days following implant and every 6 months.
Detailed Description
The purpose of this prospective, non-randomized, single arm, event-based, multicenter trial is to assess: (1) the diagnostic accuracy of the device, (2) the compliance of the prescribing physician, (3) the experience of the implanting physician, (4) the experience of the emergency department physician and (5) the patient compliance for "Emergency" and "See Doctor" alerts. The adequacy of the training program for the prescribing physician, implanting physician, emergency department physician, and patients will be assessed. A minimum of 500 patients who have had prior ACS events and who remain at high risk for recurrent ACS events will be enrolled in the PAS, for the purpose of accruing 314 adjudicated True Positive (TP) or False Positive (FP) ACS events. These ACS events will contribute to the Positive Predictive Value (PPV) and false positive rate (FPR) endpoints of the study. The PAS will be completed once the 314 ACS events have been collected and adjudicated.
Eligibility Criteria
Age Range: 21 years to No maximum
Interventions
PMA P150009 AngelMed Guardian® System
Conditions
Locations
Phoenix Heart
Glendale, Arizona 85306
United States
Arizona Heart & Vascular Clinic
Glendale, Arizona 85308
United States
Southwest Cardiovascular Associates
Mesa, Arizona 85208
United States
East Los Angeles Cardiology
Los Angeles, California 90033
United States
Orange County Heart and Research Institute
Orange, California 92868
United States
Clermont Ambulatory Surgical Center
Clermont, Florida 34711
United States
Daytona Heart Group
Daytona Beach, Florida 32114
United States
Florida Heart Rhythm Specialists
Fort Lauderdale, Florida 33308
United States
Institute for Cardiovascular Research Studies, Inc.
Miami, Florida 33176
United States
LEJ Medical, LLC
New Smyrna Beach, Florida 32168
United States
Northside Hospital Cardiovascular Institute
Atlanta, Georgia 30342
United States
Cardiovascular Associate Research
Covington, Louisiana 70433
United States
Heart Clinic of Hammond
Hammond, Louisiana 70403
United States
North Shore Heart and Vascular
Mandeville, Louisiana 70448
United States
Corewell Health
Grand Rapids, Michigan 49503
United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma 73135
United States
Texan Cardiovascular Institute
El Paso, Texas 79915
United States
Medical City Hospital Forth Worth
Fort Worth, Texas 76104
United States