- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02188147
Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study (ASAP)
Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study Protocol
Study Overview
Status
Conditions
Intervention / Treatment
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 discharge from the emergency department (ED). Observational data will be collected to assess the logistics of equipping patients with the device and providing training in the ED, and the ability of patients to receive follow-up care on an outpatient basis. In addition, data will be collected to confirm that the device meets expected safety. The experience gained from this stage of the study will be used to guide future studies of device's functionality enhancements and definitive device safety and efficacy.
STUDY POPULATION Participants will be patients presenting to the ED following a syncope event which has been defined as cardiac, or potentially cardiac, i.e. undiagnosed in nature.
INTERVENTION A wearable defibrillator optimized for short-term ambulatory use with adhesive electrodes will be prescribed for up to 14 days of use following emergency department discharge or until the physician responsible for the subject's care defines an alternative treatment plan.
STUDY DESIGN This is a single-arm feasibility study.
STUDY SIZE The study will enroll a minimum of 50 and a maximum of 80 subjects. A maximum of 20 centers will be used for enrollment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Connecticut
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Danbury, Connecticut, United States
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Florida
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Jacksonville, Florida, United States
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Minnesota
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Minneapolis, Minnesota, United States
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Saint Paul, Minnesota, United States
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New York
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Staten Island, New York, United States
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Ohio
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Cincinnati, Ohio, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SWD 1000
Short Term Wearable Defibrillator
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Short-term Wearable Defibrillator (SWD 1000)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device Unable to Monitor Due to ECG Noise
Time Frame: enrollment to 30 days
|
% time the device detected noise on both leads at the same time.
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enrollment to 30 days
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Device Monitoring Using Only One ECG Lead
Time Frame: enrollment to 30 days
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% time that the device is monitoring using only one lead due to noise detected on the other lead
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enrollment to 30 days
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Followup Care Visits
Time Frame: enrollment to 30 days
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Followup care for syncope - outpatient medical care visits
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enrollment to 30 days
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ER or Hospitalization
Time Frame: enrollment to 30 days
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Followup care for syncope - returned to ER or admitted to hospital
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enrollment to 30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Use
Time Frame: enrollment to 30 days
|
Average time the SWD 1000 was used by participants
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enrollment to 30 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Steve Szymkiewicz, MD, Zoll Medical Corporation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 90D0119
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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