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NCT05412927 · ClinicalTrials.gov registry record
AngelMed Guardian® System PMA Post Approval Study
A clinical trial of Acute Coronary Syndrome, sponsored by Angel Medical Systems.
- Recruiting
- Registry status
- 500
- Enrollment target
- 18
- Study locations
NCT05412927: Recruiting study of Acute Coronary Syndrome, sponsored by Angel Medical Systems.
NCT05412927 is a study of Acute Coronary Syndrome that is actively recruiting participants, run by Angel Medical Systems. The registered enrollment target is 500 participants, below the 2,709-participant average among 40 other Acute Coronary Syndrome trials with a reported enrollment target (82% lower). The trial reports 18 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05412927, a study of Acute Coronary Syndrome, is actively recruiting participants, sponsored by Angel Medical Systems.
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 18
- Study locations
Study 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.
Primary Outcome
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 Posi
Conditions Studied
Interventions
- DEVICE PMA P150009 AngelMed Guardian® System
Study Locations (18)
Florida
- Clermont Ambulatory Surgical Center - Clermont
- Daytona Heart Group - Daytona Beach
- Florida Heart Rhythm Specialists - Fort Lauderdale
- Institute for Cardiovascular Research Studies, Inc. - Miami
- LEJ Medical, LLC - New Smyrna Beach
Arizona
- Phoenix Heart - Glendale
- Arizona Heart & Vascular Clinic - Glendale
- Southwest Cardiovascular Associates - Mesa
Louisiana
- Cardiovascular Associate Research - Covington
- Heart Clinic of Hammond - Hammond
- North Shore Heart and Vascular - Mandeville
California
- East Los Angeles Cardiology - Los Angeles
- Orange County Heart and Research Institute - Orange
Texas
- Texan Cardiovascular Institute - El Paso
- Medical City Hospital Forth Worth - Fort Worth
Georgia
- Northside Hospital Cardiovascular Institute - Atlanta
Michigan
- Corewell Health - Grand Rapids
Oklahoma
- South Oklahoma Heart Research - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2022-09-07 |
| Est. Completion | 2026-12 |
What NCT05412927 shows while recruiting
NCT05412927 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 2,709-participant average among 40 other Acute Coronary Syndrome trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Acute Coronary Syndrome appearing as the primary indexed condition, and to 1 intervention - of which PMA P150009 AngelMed Guardian® System is the first listed.
NCT05412927 lists 18 locations in 8 states (Florida, Arizona, Louisiana).
Frequently Asked Questions
What is clinical trial NCT05412927 about?
NCT05412927 is a clinical study titled "AngelMed Guardian® System PMA Post Approval Study". 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.
What is the current status of trial NCT05412927?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2022-09-07. Estimated completion is 2026-12.
What conditions does trial NCT05412927 study?
This clinical trial studies the following conditions: Acute Coronary Syndrome.
What interventions are being tested in trial NCT05412927?
The interventions under investigation include: PMA P150009 AngelMed Guardian® System (DEVICE).
Who is sponsoring clinical trial NCT05412927?
This trial is sponsored by Angel Medical Systems, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05412927 being conducted?
This trial has 18 study locations across Arizona, California, Florida, Georgia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Coronary Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05412927's enrollment target sits among peer trials
500 21st of 40 higher than 20 of 40 other Acute Coronary Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Coronary Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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