Defibrio AED Study

Overview

About this study

The purpose of this study is to evaluate the Defibrio AED device. The ability of the AED to successfully deploy (i.e., set up, detect, & deliver charge) and the frequency and severity of device related adverse events.

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:

  • Age ≥ 18 years

  • Weight > 25 kg

  • BMI ≤ 45

  • Able and willing to provide written informed consent before undergoing any study-related procedures

  • Scheduled for any of the following procedures:

    • Ablation of ventricular tachycardia or ventricular fibrillation

    • Electrophysiology study for induction of ventricular arrhythmias

    • Non-invasive electrophysiology testing using an existing implantable defibrillator

Exclusion Criteria:

  • Any condition that in the physician investigator’s opinion precludes the subject’s ability to comply with the study requirements

  • Pregnancy

  • Use of any temporary or permanent mechanical circulatory support (e.g. LVAD, extracorporeal membrane oxygenation, intra-aortic balloon pump or Impella)

  • Presence of a cardiac thrombus

  • Atrial fibrillation or atrial flutter without therapeutic anticoagulation or left atrial appendage occlusion device with a leak

  • Critical aortic stenosis

  • Unstable coronary artery disease (CAD)

  • Stroke or transient ischemic attack (TIA) within past 90 days

  • Hemodynamic instability

  • Unstable angina

  • New York Heart Association (NYHA) Class IV heart failure symptoms / ongoing inotrope support

  • Left Ventricular Ejection Fraction (LVEF) < 20%

  • History of inability to induce ventricular arrhythmias

  • Active Do Not Resuscitate order

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 02/04/2026. Questions regarding updates should be directed to the study team contact.

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.

Contact us for the latest status

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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