Last updated on August 2018

Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study Protocol

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Arrhythmia | Defibrillator (AICD)
  • Age: Between 18 - 90 Years
  • Gender: Male or Female

Inclusion Criteria:


Experienced a syncopal event within the past 48 hours Either one of the following profiles(A or B) apply:

A. ED workup indicates that the patient may have experienced syncope that is cardiac in nature (any one or more of the following apply:

History or diagnosis of structural heart disease History of cardiovascular disease Age ≥ 40 Palpitations experienced pre-syncope Major ECG abnormalities:

  • QRS-duration greater than 140 ms
  • PR-interval greater than 200 ms
  • Non-specific repolarization abnormality
  • Syncope experienced without any warning
  • Syncope experienced while supine
  • Syncope during exercise

 B. ED workup does not indicate a clear cause of the syncopal event

Exclusion Criteria:

Clear diagnosis of non-cardiac syncope (e.g. orthostatic hypotensive syncope, vasovagal syncope, carotid sinus syncope, situational fainting) An active implantable cardioverter-defibrillator (ICD) An active unipolar pacemaker Significant risk or suffering a cardiovascular event such as:

Symptoms of New York Heart Association (NYHA) class III or IV heart failure ED diagnosis of acute coronary syndrome Having required resuscitation in response to the index syncopal event Advanced directive prohibiting resuscitation (DNR) 6. Physical or mental conditions preventing subjects from interacting with or wearing the device as determined by the investigating physician. 7. Bandages or other clinical condition preventing SWD 1000 use 8. Injuries or other conditions beyond simple syncope that require hospitalization 9. Travel out of town during the study participation period that prevents the field service representative from visiting the subject daily 10. Unable or unwilling to provide written informed consent

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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