N/A
N=39
Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study
Syncope
Bottom Line
View on ClinicalTrials.gov: NCT02188147 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Device Unable to Monitor Due to ECG Noise — 1.5 percentage of time worn
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Short Term Wearable Defibrillator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zoll Medical Corporation
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device Unable to Monitor Due to ECG Noise |
1.5 | — |
| PRIMARY Device Monitoring Using Only One ECG Lead |
2.5 | — |
| PRIMARY Followup Care Visits |
17 | — |
| PRIMARY ER or Hospitalization |
4 | — |
| SECONDARY Duration of Use |
6.1 | — |
Summary
The purpose of this study is to conduct an observational investigation of a novel care path used to manage emergency department (ED) presenting syncope patients on an outpatient basis.
Eligibility Criteria
Inclusion Criteria
- Age≥18
- 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)
- Physical or mental conditions preventing subjects from interacting with or wearing the device as determined by the investigating physician.
- 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
Data sourced from ClinicalTrials.gov (NCT02188147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.