Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-11 @ 10:04 AM
Study NCT ID:
NCT05412927
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2022-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AngelMed Guardian® System PMA Post Approval Study
Sponsor:
Angel Medical Systems
Organization:
Study Overview
Official Title:
AngelMed Guardian® System PMA Post Approval Study
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: