Study to Evaluate the Detection Performance and Safety of an Investigational Wearable Cardioverter Defibrillator (WCD)


About this study

The purpose of this study is to evaluate the detection performance and safety of an investigational Wearable Cardioverter defibrillator (WCD). 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Males or females, age ≥ 18 years.
  • Patients with an active Implantable Cardioverter Defibrillator (ICD).
  • Left Ventricular Ejection Fraction (LVEF) ≤ 40%, measured within the past year (12 months).
  • Able and willing to provide written informed consent before undergoing any study-related procedures.

Exclusion Criteria:

  • Any condition that by the judgement of the physician investigator precludes the subject’s ability to comply with the study requirements.
  • Any known skin allergy or sensitivity to the study garment materials that will be next to the skin.
  • Any breached or compromised skin on the upper torso that would be exacerbated by wearing the study garment.
  • Work with or are frequently around equipment that produces high electromagnetic fields, for example magnetic resonance imaging devices, power supply facilities, or welding equipment.
  • Any planned surgical or medical procedures during the participation period.
  • Any planned air travel during the participation period.
  • Cognitive and/or physical limitations that would prevent the subject from interacting with the device as intended.
  • Pregnancy.
  • Use of mechanical circulatory support, for example Left Ventricular Assist Device (LVAD) or Total Artificial Heart.
  • Implanted Cardiac Resynchronization Therapy Defibrillator (CRT-D).
  • Pacing pulse width > 1ms.
  • Simultaneous plan/prescription for Holter monitor, mobile cardiac outpatient telemetry (MCOT), Event Recorder, or in-hospital telemetry.
  • Use of any electronic medical device that is worn on or near the body requires Sponsor approval, other than continuous positive airway pressure (CPAP), continuous blood glucose monitor, or pulse oximeter oxygen saturation (SpO2) monitor.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Yongmei Cha, M.D.

Closed for enrollment

More information


Publications are currently not available

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