Status:
COMPLETED
Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study
Lead Sponsor:
Zoll Medical Corporation
Conditions:
Syncope
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
OBJECTIVES To conduct a prospective observational study assessing a unique outpatient care model in which syncope patients are provided with, and trained to use, a wearable defibrillator prior to disc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2020
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT02188147
Start Date
August 1 2014
End Date
April 15 2020
Last Update
February 21 2023
Active Locations (6)
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1
Danbury, Connecticut, United States
2
Jacksonville, Florida, United States
3
Minneapolis, Minnesota, United States
4
Saint Paul, Minnesota, United States