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.
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.
Study Type
OBSERVATIONAL
Enrollment
500
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.
Phoenix Heart
Glendale, Arizona, United States
RECRUITINGEfficacy (PPV and FPR)
This study is a post approval study aiming to gather data from FDA approved and standard of care implants using the proprietary medical device created by Angel Medical Systems, The Guardian. The study is collecting specific information from the subjects, devices and index procedure to demonstrate non-inferior performance of a now FDA approved product in a commercial setting. The diagnostic accuracy of the device will be assessed by comparing the Positive Predictive Value (PPV) and the False Positive Rate (FPR) results in the PAS to the results for the same endpoints in the ALARMS-ON group in the PMA-Amendment (i.e. including patients who both had the device implanted and alarms turned on). The hypotheses will be assessed with performance goals for both PPV and FPR.
Time frame: The PAS is a 3 year, event based study, looking to accumulate 314 ACS events. Patients will be seen for an in-office initial programming visit 7-14 days following implant and every 6 months thereafter until study exit or study completion.
Adequacy of Training Programs for Study Team and Patients
Instances where the device is prescribed/implanted for patients that don't meet proper labeling criteria. Instances of system revisions, any system problem that requires invasive corrective procedures to resolve, required within 6mo. of implant. Instances of "Emergency" alarm non-compliance, failure to report to the ER within 72 hours of the alarm. Instances of "See Doctor" noncompliance, defined as failure to present to doctor within 2 weeks of alarm or reporting to ER instead of to doctor in response to alarm. Instances of patient non-success to reconfirm ability to distinguish between "Emergency" and "See Doctor," defined by being able to report the proper actions to take for each and what to do when only symptoms occur in the absence of an alarm. Instances of percutaneous intervention without at least one positive standard of care test reported on a site-based and visit-based basis.
Time frame: The PAS is a 3 year, event based study, looking to accumulate 314 ACS events. Patients will be seen for an in-office initial programming visit 7-14 days following implant and every 6 months thereafter until study exit or study completion.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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RECRUITINGSouthwest Cardiovascular Associates
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ACTIVE_NOT_RECRUITINGEast Los Angeles Cardiology
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RECRUITINGOrange County Heart and Research Institute
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ACTIVE_NOT_RECRUITINGClermont Ambulatory Surgical Center
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RECRUITINGDaytona Heart Group
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RECRUITINGFlorida Heart Rhythm Specialists
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RECRUITINGInstitute for Cardiovascular Research Studies, Inc.
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RECRUITINGLEJ Medical, LLC
New Smyrna Beach, Florida, United States
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