Clinical trial: Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study (NCT02188147)

Eligibility criteria:
Inclusion Criteria:

          1. Age≥18

          2. Experienced a syncopal event within the past 48 hours

          3. 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:

          1. Clear diagnosis of non-cardiac syncope (e.g. orthostatic hypotensive syncope,
             vasovagal syncope, carotid sinus syncope, situational fainting)

          2. An active implantable cardioverter-defibrillator (ICD)

          3. An active unipolar pacemaker

          4. 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 23-year-old man comes to the emergency department following an episode of syncope.  He was working out when he felt dizzy and passed out without head injury.  He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions.  The patient does not use tobacco, alcohol, or illicit drugs.  His father died suddenly at age 35.  Vital signs are within normal limits.  On physical examination, the patient has a harsh systolic murmur.  The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy.

Patient description (patient's own words): I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average.

Does the patient match the trial criteria? Contradiction