A Study to Collect Electrical Signals From the Heart Using a Special Lead


About this study

The purpose of this study is to collect electrogram data from an investigational lead placed in an extravascular space, for the development of a future Implantable Cardioverter Defibrillator (ICD) system.

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

  • Must be undergoing surgical procedure for approved indications for
    • Cardiothoracic surgery where a midline sternotomy is planned
    • Cardiothoracic surgery where a subxiphoid/paraxiphoid cut for a chest tube is planned
    • VT ablation procedure with epicardial access
    • Implant of a subcutaneous ICD (S-ICD®)
    • Implant of a transvenous ICD (single or dual chamber)
  • Must be willing to provide informed consent
  • Must be ≥ 18 years old

Exclusion Criteria

  • Has known hiatus hernia, or moderate or worse pectus excavatum
  • Had previous pericarditis or prior sternotomy
  • Has known significant Right Ventricle/ Right Ventricular dilation
  • Has hypertrophic cardiomyopathy
  • Is pacemaker dependent
  • Has known skin irritations due to the Covidien Multi-function defibrillation electrode
  • Is considered to be at high risk for infection
  • Has Left Ventricular Ejection Fraction < 20% (most recent available LVEF measurement in the last 6 months)
  • Has New York Heart Association Class IV
  • Has myocardial infarction within the last 6 weeks
  • Currently has unstable angina
  • Has severe aortic stenosis
  • Is at high risk of stroke
  • Has chronic obstructive pulmonary disease and is oxygen dependent
  • Has permanent AF and will not be adequately anticoagulated during the ASD2 Acute Testing procedure
  • Has an implanted active cardiac or non-cardiac device during the ASD2 acute testing procedure (e.g., ICD, S-ICD®, Pacemaker, Neuro stimulator)
  • Is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
  • Has any medical condition that would limit study participation
  • Is pregnant, or of childbearing potential and not on a reliable form of birth control
  • Women of childbearing potential are required to have a negative pregnancy test within 7 days prior to the ASD2 acute testing procedure
  • Meets exclusion criteria required by local law (e.g. age, breast feeding,etc.)
  • Is legally incompetent
    • If at high risk for infection, decision will be based on the local investigator judgment decision
    • If at high risk for stroke should be screened according to local country guidelines or, in case of their absence, according to ACC/AHA/ESC 2006 Guidelines for High Risk Factors for Stroke (i.e. exclusion of subjects with previous stroke, TIA, or embolism; Mitral stenosis; prosthetic heart valve).
    • Screening will be based on the local investigator judgment decision

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

Yong-Mei Cha, M.D.

Closed for enrollment

More information


Publications are currently not available

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