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Implantable heart attack alert device tested in Real-World patients

NCT ID NCT05412927

Disease control Sponsor: Angel Medical Systems Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 500 people who already have or will get the AngelMed Guardian® implant, a device that monitors heart signals and alerts patients to possible heart attacks. Participants are high-risk heart patients with conditions like diabetes or prior heart attacks. The goal is to see how well the device works in everyday use and whether it reduces false alarms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AngelMed Guardian® System (implantable cardiac monitor with patient alert)
What this could lead to
If successful, this could confirm the device helps high-risk heart patients get faster treatment for recurrent heart attacks.
What could go wrong
This is an observational post-approval study, not a randomized trial, so it cannot prove the device improves outcomes. False alarms may cause unnecessary worry or hospital visits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population includes patients who have had prior ACS events and who remain at high risk for recurrent ACS events. Patients will be identified by implanting physicians using standard of care requirements for elective commercial implants based on the appropriate labeling and indications for use of the AngelMed Guardian System.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\. Subject has at least one of the following conditions: 1. Diabetes (Type I or Type II) 2. Compromised renal function (Cr \> 1.2 mg/dl or creatinine clearance less than 50) 3. TIMI Risk Score of at least 3 2\. Previously diagnosed with a high-risk acute coronary syndrome (e.g., Unstable Angina, STEMI or NSTEMI) or has undergone or is scheduled for CABG within 6 months of implantation. 3\. Has already undergone coronary angiography and revascularization, unless the physician determines it is appropriate to implant before or during the planned procedure. 4\. Lives in a geographic area in close proximity (within approximately 60 minutes by EMS) to any hospital that can treat AMI. 5\. Subjects (men or women) at least 21 years of age. Women of childbearing age must have a negative pregnancy test or confirmation of one of the following: <!-- --> 1. Post-menopause or amenorrhoeic during the past year 2. Surgical sterilization 3. Use of effective contraceptive method Exclusion Criteria: * 1\. In the investigator's opinion, subject lacks ability to respond appropriately to alarms, e.g., illiteracy, poor memory or cognitive function, dementia or other condition affecting memory function, etc. 2\. There is known compromised tissue at the site of lead implantation in the apex of the right ventricle, e.g., prior infarct affecting the RV apex location. 3\. A permanent pacemaker or ICD is already in place or the subject is indicated for ICD or pacemaker implantation based on the guidelines published by the American College of Cardiology as Class I and IIa recommendations. Class IIb recommendations are at the investigator's discretion. 4\. Subject cannot feel the IMD vibration when placed on top of the skin on the left pectoral side of the chest. 5\. Subject has recurrent or persistent atrial fibrillation. 6. Subject has recurrent or persistent non-sinus cardiac rhythm, second or third degree atrioventricular blocks, QRS duration greater than 120 ms, Benign Early Repolarization (BER), Brugada Syndrome (LLB, BBB, RBB) or Rate Induced BBB. 7\. Subject has left ventricular hypertrophy evidenced by EKG criteria. 8. Subject has any condition preventing the subcutaneous implantation of the Guardian® System in a left pectoral pouch, such as: superior vena cava thrombosis, subcutaneous tissue deemed inappropriate for the procedure or prior central venous access via portacath, Hickman, Groshong, or similar placed in a left pectoral location or left side PICC line. 9\. Subject has extremely heavy alcohol consumption (participates in binge drinking that leads to alcohol intoxication) or has history of alcohol or illicit drug abuse within past 5 years. 10\. There is evidence of unresolved infection (fever \> 38o C and/or leukocytosis \> 15,000). 11\. Subject has history of bleeding disorders or severe coagulopathy (platelets \< 100,000 plts/ml; APTT or PT \> 1.3 x reference range). 12\. Subject has had a hemorrhagic stroke or transient ischemic attack (TIA) in the past 6 months. 13\. Subject has a potentially fatal disease, such as cancer or refractory congestive heart failure, associated with limitation of life expectancy, which may lead to inadequate compliance to the protocol or confusing data interpretation. 14\. Subject has clinical conditions such as heart diseases, difficult-to-control blood pressure, difficult-to-control insulin-dependent diabetes or serious prior infections attributed to the diabetes, or others that, at the investigator's discretion, could seriously affect the subject's current clinical condition during study procedures. 15\. Subject has previously been implanted with an AngelMed Guardian® System, current participation or previous participation in another drug or device study in the past 30 days that conflicts with this study as determined by the study sponsor. 16\. Subject has experienced gastro-intestinal hemorrhage in the past 6 months. 17. Subject has any situation in which the use of aspirin is contraindicated for at least 6 months. 18\. Subject has epilepsy. 19. Subject has known severe allergies, e.g., peanut, bee sting, etc. 20. Subject has a known coronary occlusion that cannot be reperfused e.g. known multiple small vessel disease, saphenous vein graft, prior angiography where doctor could not intervene, or jailed occlusion.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute coronary syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arizona Heart & Vascular Clinic

    RECRUITING

    Glendale, Arizona, 85308, United States

  • Cardiovascular Associate Research

    ACTIVE_NOT_RECRUITING

    Covington, Louisiana, 70433, United States

  • Clermont Ambulatory Surgical Center

    RECRUITING

    Clermont, Florida, 34711, United States

  • Corewell Health

    ACTIVE_NOT_RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Daytona Heart Group

    RECRUITING

    Daytona Beach, Florida, 32114, United States

  • East Los Angeles Cardiology

    RECRUITING

    Los Angeles, California, 90033, United States

  • Florida Heart Rhythm Specialists

    RECRUITING

    Fort Lauderdale, Florida, 33308, United States

  • Heart Clinic of Hammond

    RECRUITING

    Hammond, Louisiana, 70403, United States

  • Institute for Cardiovascular Research Studies, Inc.

    RECRUITING

    Miami, Florida, 33176, United States

  • LEJ Medical, LLC

    SUSPENDED

    New Smyrna Beach, Florida, 32168, United States

  • Medical City Hospital Forth Worth

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • North Shore Heart and Vascular

    ACTIVE_NOT_RECRUITING

    Mandeville, Louisiana, 70448, United States

  • Northside Hospital Cardiovascular Institute

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Orange County Heart and Research Institute

    ACTIVE_NOT_RECRUITING

    Orange, California, 92868, United States

  • Phoenix Heart

    RECRUITING

    Glendale, Arizona, 85306, United States

  • South Oklahoma Heart Research

    RECRUITING

    Oklahoma City, Oklahoma, 73135, United States

  • Southwest Cardiovascular Associates

    ACTIVE_NOT_RECRUITING

    Mesa, Arizona, 85208, United States

  • Texan Cardiovascular Institute

    RECRUITING

    El Paso, Texas, 79915, United States

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