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Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study (ASAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02188147
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Zoll Medical Corporation

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.

Condition or disease Intervention/treatment Phase
Syncope Device: Short Term Wearable Defibrillator Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study Protocol
Actual Study Start Date : August 2014
Actual Primary Completion Date : April 2020
Actual Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arm Intervention/treatment
Experimental: SWD 1000
Short Term Wearable Defibrillator
Device: Short Term Wearable Defibrillator
Short-term Wearable Defibrillator (SWD 1000)




Primary Outcome Measures :
  1. Percentage of time rhythm monitoring by the Short-term Wearable Defibrillator (SWD1000) is compromised due to ECG noise. [ Time Frame: Device use is expected to last at least 24 hours and no more than 14 days ]
    The amount of time that the SWD1000 is able to effectively monitor the subject's rhythm status is the primary safety measure. It is expected that monitoring will be inhibited by noise no greater than 2% of the time worn and monitoring using single lead analysis will be no greater than 5% of the time worn.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188147


Locations
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United States, Connecticut
Danbury, Connecticut, United States
United States, Florida
Jacksonville, Florida, United States
United States, Minnesota
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
United States, New York
Staten Island, New York, United States
United States, Ohio
Cincinnati, Ohio, United States
Sponsors and Collaborators
Zoll Medical Corporation
Investigators
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Study Director: Steve Szymkiewicz, MD Zoll Medical Corporation
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Responsible Party: Zoll Medical Corporation
ClinicalTrials.gov Identifier: NCT02188147    
Other Study ID Numbers: 90D0119
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Keywords provided by Zoll Medical Corporation:
Syncope
Sudden Cardiac Arrest
Sudden Cardiac Death
Cardiac Arrest
Emergency Service
Emergency Department
Ambulatory Electrocardiography
Holter
Holter Electrocardiography
Holter Monitoring
Additional relevant MeSH terms:
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Syncope
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms