Clinical trial NCT05412927: AngelMed Guardian® System PMA Post Approval Study
Official title: AngelMed Guardian® System PMA Post Approval Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndrome
Lead sponsor: Angel Medical Systems
Sponsor class: INDUSTRY
First posted: 2022-06-09
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

Eligibility criteria: 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:

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  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.

Primary outcomes:
measure: Efficacy (PPV and FPR)
timeFrame: 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:
measure: Adequacy of Training Programs for Study Team and Patients
timeFrame: 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.
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Southwest Cardiovascular Associates
state: Arizona
city: Los Angeles
country: United States
facility: East Los Angeles Cardiology
state: California
city: Orange
country: United States
facility: Orange County Heart and Research Institute
state: California
city: Clermont
country: United States
facility: Clermont Ambulatory Surgical Center
state: Florida
city: Fort Lauderdale
country: United States
facility: Florida Heart Rhythm Specialists
state: Florida
city: Miami
country: United States
facility: Institute for Cardiovascular Research Studies, Inc.
state: Florida
city: New Smyrna Beach
country: United States
facility: LEJ Medical, LLC
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital Cardiovascular Institute
state: Georgia
city: Covington
country: United States
facility: Cardiovascular Associate Research
state: Louisiana
city: Hammond
country: United States
facility: Heart Clinic of Hammond
state: Louisiana
city: Mandeville
country: United States
facility: North Shore Heart and Vascular
state: Louisiana
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Oklahoma City
country: United States
facility: South Oklahoma Heart Research
state: Oklahoma
city: El Paso
country: United States
facility: Texan Cardiovascular Institute
state: Texas
city: Fort Worth
country: United States
facility: Medical City Hospital Forth Worth
state: Texas
Study officials:
affiliation: Angel Medical Systems Inc.
name: David Keenan
role: STUDY_DIRECTOR
affiliation: Angel Medical Systems Inc.
name: Sasha John, PhD
role: STUDY_DIRECTOR
affiliation: Hackensack-Meridian Health Care System
name: Haroon Faraz, MD
role: PRINCIPAL_INVESTIGATOR
References: