AngelMed Guardian® System PMA Post Approval Study

Conditions

• Acute Coronary Syndrome

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PMA P150009 AngelMed Guardian® System — DEVICE
  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 Details

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.

Key Dates

Start date

Sep 7, 2022

Status verified

Sep 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

500 participants (estimated)

Arms

• Arm: 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.

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. ]

Central Contacts

• Jacqueline Finley, BS
  732.542.5551
  [email protected]
• Sasha John, PhD
  6466444661
  [email protected]

Locations (18)

Find similar trials in Glendale, AZ

Related Studies

• Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS
  PHASE3 · Recruiting · DalCor Pharmaceuticals · Alexander City, Alabama
• A Polypill for Acute Coronary Syndrome
  PHASE2 · Recruiting · University of Texas Southwestern Medical Center · Dallas, Texas
• Positive Emotions Following Acute Cardiac Events
  Recruiting · Massachusetts General Hospital · Boston, Massachusetts
• Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock
  Recruiting · University of Minnesota · Minneapolis, Minnesota