AngelMed Guardian® System PMA Post Approval Study

STUDY OVERVIEW

Following commercial implantation of the Guardian device, developed by Angel Medical Systems, a minimum of 500 patients will be enrolled and treated by their physicians using the standard of care. This standard includes an initial programming visit 7-14 days post-implantation and subsequent visits every 6 months thereafter.

STUDY GOALS

The goal of this prospective, non-randomized, single-arm, event-based, multicenter trial is to evaluate the Guardian device's diagnostic accuracy and various stakeholders' experiences and compliance. This study aims to assess the compliance of prescribing physicians, implanting physicians, emergency department physicians, and patients regarding "Emergency" and "See Doctor" alerts. Additionally, it aims to evaluate the adequacy of the training program for these stakeholders. A minimum of 500 patients with prior acute coronary syndrome (ACS) events, at high risk for recurrence, will be enrolled to collect and adjudicate 314 ACS events, contributing to the determination of positive predictive value (PPV) and false positive rate (FPR) endpoints.

LOCATION

El Paso, Texas: Texas Cardiovascular Institute

INCLUSION CRITERIA

  • Female, 18-44 years old, with one of the following conditions: diabetes, compromised renal function, or TIMI Risk Score > 3, and high-risk acute coronary syndrome or scheduled for CABG within 6 months.

  • Lives within 60 minutes of a hospital equipped to treat acute myocardial infarction.

  • Men or women at least 21 years old; women of childbearing age must have negative pregnancy test or meet specific criteria.

exclusion criteria

  •     Inability to respond to alarms.

  •     Compromised tissue at the lead implantation site.

  •     Already has a permanent pacemaker or ICD, or indicated for one based on guidelines.

  •     Cannot feel IMD vibration.

  •     Presence of specific cardiac conditions.

  •     Left ventricular hypertrophy.

  •     Conditions preventing implantation of the Guardian® System.

  •     History of heavy alcohol consumption or substance abuse.

  •     Evidence of unresolved infection or bleeding disorders.

  •     Recent hemorrhagic stroke or TIA.

  •     Severe diseases impacting life expectancy or compliance.

  •     Clinical conditions affecting current condition during study.

  •     Previous implantation of an AngelMed Guardian® System or recent participation in conflicting studies.

  •     Gastrointestinal hemorrhage or contraindication to aspirin.

  •     Epilepsy or severe allergies.

  •     Known coronary occlusion that cannot be reperfused.

Study Population: Patients with prior ACS events at high risk for recurrence, identified by implanting physicians based on standard-of-care requirements for commercial AngelMed Guardian System implants.

For more information, visit ClinicalTrials.gov.