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
|Condition or disease||Intervention/treatment||Phase|
|Syncope||Device: Short Term Wearable Defibrillator||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|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|
Experimental: SWD 1000
Short Term Wearable Defibrillator
Device: Short Term Wearable Defibrillator
Short-term Wearable Defibrillator (SWD 1000)
- 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.
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
|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|
|Study Director:||Steve Szymkiewicz, MD||Zoll Medical Corporation|