Acute Coronary SyndromeNCT05412927
AngelMed Guardian® System PMA Post Approval Study
An observational study of Acute Coronary Syndrome, run by Angel Medical Systems at 18 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- PMA P150009 AngelMed Guardian® System
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 18 sitesUnited States
- Study dates
- 7 Sep 2022to Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 1. Subject has at least one of the following conditions:
- Diabetes (Type I or Type II)
- Compromised renal function (Cr > 1.2 mg/dl or creatinine clearance less than 50)
- 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.
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- 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:
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- Post-menopause or amenorrhoeic during the past year
- Surgical sterilization
- Use of effective contraceptive method
Who cannot join
- 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.
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- 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.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites, 12 recruiting
- Recruiting
Northside Hospital Cardiovascular Institute
Atlanta, Georgia, 30342
Tamara Wakhisi, CCRP, 404-236-8322, tamara.wakhisi@northside.com
Katie Moore, 404-236-8320, katie.moore@northside.com
- Recruiting
Clermont Ambulatory Surgical Center
Clermont, Florida, 34711
Saif Memon, 407-965-9848, saifoomemon@gmail.com
Usman Siddiqui, MD
- Active, not recruiting
Cardiovascular Associate Research
Covington, Louisiana, 70433
- Recruiting
Daytona Heart Group
Daytona Beach, Florida, 32114
Jennifer Langdon, 386-258-8722, jlangdonresearch@yahoo.com
Glenn Rayos, MD
- Recruiting
Texan Cardiovascular Institute
El Paso, Texas, 79915
Christy Willis, NP, 915-867-7860, christywillis@texanasc.com
Ali Nasur, MD
- Recruiting
Florida Heart Rhythm Specialists
Fort Lauderdale, Florida, 33308
Carlos Guadamas, 954-678-9531, carlos.guadamas@flahrs.com
David Kenigsberg, MD
- Recruiting
Medical City Hospital Forth Worth
Fort Worth, Texas, 76104
Sarma Bhagawathy, MD, 817-201-7419, bhagawathy.sarma@hcahealthcare.com
Amir Malik, MD
- Recruiting
Phoenix Heart
Glendale, Arizona, 85306
Anthony Loaiza, 602-228-0600, aloaiza@phoenixheart.com
Andrew Kaplan, MD
- Recruiting
Arizona Heart & Vascular Clinic
Glendale, Arizona, 85308
Delora Multhauf, 480-760-3084, delora@azheartandvascular.com
Rahul Malhotra, MD
- Active, not recruiting
Corewell Health
Grand Rapids, Michigan, 49503
- Recruiting
Heart Clinic of Hammond
Hammond, Louisiana, 70403
Lisa Bica, 586-943-8867, lbica@theheartclinics.com
Karla Gorio, PA
- Recruiting
East Los Angeles Cardiology
Los Angeles, California, 90033
Prash Jayaraj, MD, 323-578-0078, drjraj@yahoo.com
Suresh Rao, MD
- Active, not recruiting
North Shore Heart and Vascular
Mandeville, Louisiana, 70448
- Active, not recruiting
Southwest Cardiovascular Associates
Mesa, Arizona, 85208
- Recruiting
Institute for Cardiovascular Research Studies, Inc.
Miami, Florida, 33176
Ruben Dominguez, 305-905-7389, ruben.dominguez@cardioresearchstudies.com
Efrain Gonzalez, MD
- Suspended
LEJ Medical, LLC
New Smyrna Beach, Florida, 32168
- Recruiting
South Oklahoma Heart Research
Oklahoma City, Oklahoma, 73135
Julie White, BS, 405-628-6865, juliewhite@okheart.com
Asim Chohan, MD
- Active, not recruiting
Orange County Heart and Research Institute
Orange, California, 92868
About this 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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- PMA P150009 AngelMed Guardian® System
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMA P150009 AngelMed Guardian® SystemDevice
The AngelMed Guardian® System is an implantable cardiac monitor with patient alerting capability and an additional external alarm device. The Guardian® System is indicated for use in patients who have had prior ACS events and who remain at high risk for recurrent ACS events. The Guardian® System is indicated as an adjunct to patient recognized symptoms. The Guardian® System detects potential ongoing ACS events, characterized by sustained ST segment changes, and alerts the patient to seek medical attention for those potential ACS events.
A Guardian® System alert is a more accurate predictor of ACS events when compared to patient recognized symptoms alone and demonstrates a reduced rate over time of patient presentations without ACS events (false positives) when compared to patient recognized symptoms alone. In the absence of symptoms, the Guardian® System may identify asymptomatic ACS events and prompt the patient to seek medical attention.
| Study group | Role | What they receive |
|---|---|---|
| Patients who have had prior ACS events. | Patients who have had prior ACS events and who remain at high risk for recurrent ACS events will be implanted with PMA P150009 AngelMed Guardian® System and enrolled in the PAS, for the purpose of accruing 314 adjudicated True Positive (TP) or False Positive (FP) ACS events. Receives: Device: PMA P150009 AngelMed Guardian® System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (PPV and FPR)
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 Positive Rate (FPR) results in the PAS to the results for the same endpoints in the ALARMS-ON group in the PMA-Amendment (i.e. including patients who both had the device implanted and alarms turned on). The hypotheses will be assessed with performance goals for both PPV and FPR.
Measured: The PAS is a 3 year, event based study, looking to accumulate 314 ACS events. Patients will be seen for an in-office initial programming visit 7-14 days following implant and every 6 months thereafter until study exit or study completion.
Secondary outcomes (1)
Adequacy of Training Programs for Study Team and Patients
Instances where the device is prescribed/implanted for patients that don't meet proper labeling criteria. Instances of system revisions, any system problem that requires invasive corrective procedures to resolve, required within 6mo. of implant. Instances of "Emergency" alarm non-compliance, failure to report to the ER within 72 hours of the alarm. Instances of "See Doctor" noncompliance, defined as failure to present to doctor within 2 weeks of alarm or reporting to ER instead of to doctor in response to alarm. Instances of patient non-success to reconfirm ability to distinguish between "Emergency" and "See Doctor," defined by being able to report the proper actions to take for each and what to do when only symptoms occur in the absence of an alarm. Instances of percutaneous intervention without at least one positive standard of care test reported on a site-based and visit-based basis.
Measured: The PAS is a 3 year, event based study, looking to accumulate 314 ACS events. Patients will be seen for an in-office initial programming visit 7-14 days following implant and every 6 months thereafter until study exit or study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start7 Sep 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Angel Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Keenan, Study director, Angel Medical Systems Inc.Sasha John, PhD, Study director, Angel Medical Systems Inc.Haroon Faraz, MD, Principal investigator, Hackensack-Meridian Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412927
- Sponsor's protocol ID
- 2301-001
- Status last verified
- Sep 2025
- First submitted
- 1 Jun 2022
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The study doctor will collect your personal and medical information. For example: * Past and present medical records * Research records * Records about phone calls made as part of this research * Records about your study visits Your information may be given to: * The U.S. Food and Drug Administration (FDA), * Department of Health and Human Services (DHHS) agencies, * Governmental agencies in other countries, * Governmental agencies to whom certain diseases (reportable diseases) must be reported * Central IRB Why will this information be used and/or given to others? * to do the research, * to study the results, and * to see if the research was done right.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AngelMed Guardian® System PMA Post Approval Study
- ClinicalTrials.gov ID
- NCT05412927
- Acronym / sponsor ID
- 2301-001
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Angel Medical SystemsIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who have had prior ACS events. | – | Device: PMA P150009 AngelMed Guardian® SystemPatients who have had prior ACS events and who remain at high risk for recurrent ACS events will be implanted with PMA P150009 AngelMed Guardian® System and enrolled in the PAS, for the purpose of accruing 314 adjudicated True Positive (TP) or False Positive (FP) ACS events. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (12 listed)
- 1. Subject has at least one of the following conditions:
- 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:
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PMA P150009 AngelMed Guardian® SystemThe AngelMed Guardian® System is an implantable cardiac monitor with patient alerting capability and an additional external alarm device. The Guardian® System is indicated for use in patients who have had prior ACS events and who remain at high risk for recurrent ACS events. The Guardian® System is indicated as an adjunct to patient recognized symptoms. The Guardian® System detects potential ongoing ACS events, characterized by sustained ST segment changes, and alerts the patient to seek medical attention for those potential ACS events. A Guardian® System alert is a more accurate predictor of ACS events when compared to patient recognized symptoms alone and demonstrates a reduced rate over time of patient presentations without ACS events (false positives) when compared to patient recognized symptoms alone. In the absence of symptoms, the Guardian® System may identify asymptomatic ACS events and prompt the patient to seek medical attention. | Device | Patients who have had prior ACS events. |
Primary outcome
Efficacy (PPV and FPR)
Time frame: The PAS is a 3 year, event based study, looking to accumulate 314 ACS events. Patients will be seen for an in-office initial programming visit 7-14 days following implant and every 6 months thereafter until study exit or study completion.
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 Positive Rate (FPR) results in the PAS to the results for the same endpoints in the ALARMS-ON group in the PMA-Amendment (i.e. including patients who both had the device implanted and alarms turned on). The hypotheses will be assessed with performance goals for both PPV and FPR.
1 secondary outcome
Adequacy of Training Programs for Study Team and Patients
Time frame: The PAS is a 3 year, event based study, looking to accumulate 314 ACS events. Patients will be seen for an in-office initial programming visit 7-14 days following implant and every 6 months thereafter until study exit or study completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: Yes. The study doctor will collect your personal and medical information. For example: * Past and present medical records * Research records * Records about phone calls made as part of this research * Records about your study visits Your information may be given to: * The U.S. Food and Drug Administration (FDA), * Department of Health and Human Services (DHHS) agencies, * Governmental agencies in other countries, * Governmental agencies to whom certain diseases (reportable diseases) must be reported * Central IRB Why will this information be used and/or given to others? * to do the research, * to study the results, and * to see if the research was done right.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Keenan study director
Angel Medical Systems Inc.
Sasha John, PhD study director
Angel Medical Systems Inc.
Haroon Faraz, MD principal investigator
Hackensack-Meridian Health Care System
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Angel Medical Systems at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacqueline Finley, BS (732.542.5551 ext. 106, jfinley@avertix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (PPV and FPR) (time frame: The PAS is a 3 year, event based study, looking to accumulate 314 ACS events. Patients will be seen for an in-office initial programming visit 7-14 days following implant and every 6 months thereafter until study exit or study completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.