AngelMed Guardian® System PMA Post Approval Study
1 other identifier
observational
500
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2022
CompletedFirst Posted
Study publicly available on registry
June 9, 2022
CompletedStudy Start
First participant enrolled
September 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
September 30, 2025
September 1, 2025
4.2 years
June 1, 2022
September 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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
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.
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- \. 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
- \. 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.
- \. Has already undergone coronary angiography and revascularization, unless the physician determines it is appropriate to implant before or during the planned procedure.
- \. Lives in a geographic area in close proximity (within approximately 60 minutes by EMS) to any hospital that can treat AMI.
- \. 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
You may not qualify if:
- \. 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.
- \. 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.
- \. 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.
- \. Subject cannot feel the IMD vibration when placed on top of the skin on the left pectoral side of the chest.
- \. 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.
- \. 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.
- \. 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.
- \. There is evidence of unresolved infection (fever \> 38o C and/or leukocytosis \> 15,000).
- \. Subject has history of bleeding disorders or severe coagulopathy (platelets \< 100,000 plts/ml; APTT or PT \> 1.3 x reference range).
- \. Subject has had a hemorrhagic stroke or transient ischemic attack (TIA) in the past 6 months.
- \. 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.
- \. 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.
- \. 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.
- \. 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.
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Phoenix Heart
Glendale, Arizona, 85306, United States
Arizona Heart & Vascular Clinic
Glendale, Arizona, 85308, United States
Southwest Cardiovascular Associates
Mesa, Arizona, 85208, United States
East Los Angeles Cardiology
Los Angeles, California, 90033, United States
Orange County Heart and Research Institute
Orange, California, 92868, United States
Clermont Ambulatory Surgical Center
Clermont, Florida, 34711, United States
Daytona Heart Group
Daytona Beach, Florida, 32114, United States
Florida Heart Rhythm Specialists
Fort Lauderdale, Florida, 33308, United States
Institute for Cardiovascular Research Studies, Inc.
Miami, Florida, 33176, United States
LEJ Medical, LLC
New Smyrna Beach, Florida, 32168, United States
Northside Hospital Cardiovascular Institute
Atlanta, Georgia, 30342, United States
Cardiovascular Associate Research
Covington, Louisiana, 70433, United States
Heart Clinic of Hammond
Hammond, Louisiana, 70403, United States
North Shore Heart and Vascular
Mandeville, Louisiana, 70448, United States
Corewell Health
Grand Rapids, Michigan, 49503, United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma, 73135, United States
Texan Cardiovascular Institute
El Paso, Texas, 79915, United States
Medical City Hospital Forth Worth
Fort Worth, Texas, 76104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David Keenan
Angel Medical Systems Inc.
- STUDY DIRECTOR
Sasha John, PhD
Angel Medical Systems Inc.
- PRINCIPAL INVESTIGATOR
Haroon Faraz, MD
Hackensack-Meridian Health Care System
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2022
First Posted
June 9, 2022
Study Start
September 7, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
September 30, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- The investigator is responsible for the preparation (review and signature) and/or retention of the records below. The following records are subject to inspection and must be retained for a period of two years after the date on which the study is terminated or completed.
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.