AngelMed Guardian® System PMA Post Approval Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Acute Coronary Syndrome

Clinical Trial Details

NCT number	NCT05412927
Study type	Observational [Patient Registry]
Source	Angel Medical Systems
Contact	Jarrod Goodarz, BS
Phone	16095082002
Email	jgoodarz@angel-med.com
Status	Recruiting
Phase
Start date	September 7, 2022
Completion date	December 2026

View Details

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