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AngelMed Guardian® System PMA Post Approval Study
NCT05412927 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05412927
The ClinicalTrials.gov registry entry for NCT05412927 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Angel Medical Systems, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05412927 reports 18 study locations spanning 8 distinct geographic areas — top geographies include Florida, Arizona, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05412927?
The interventions under investigation include: PMA P150009 AngelMed Guardian® System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05412927?
This trial is sponsored by Angel Medical Systems, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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