SyncopeASAPNCT02188147
Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study
A study testing Short Term Wearable Defibrillator in people with Syncope, run by Zoll Medical Corporation at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope
- What is being tested?
- Short Term Wearable Defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2014to 15 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18
- Experienced a syncopal event within the past 48 hours
- Either one of the following profiles(A or B) apply:
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Cincinnati, Ohio
Study site
Danbury, Connecticut
Study site
Jacksonville, Florida
Study site
Minneapolis, Minnesota
Study site
Saint Paul, Minnesota
Study site
Staten Island, New York
About this study
Official title: Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study Protocol
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.
Read the 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.
- Conditions
- Syncope
- Being tested
- Short Term Wearable Defibrillator
- Keywords
- Syncope, Sudden Cardiac Arrest, Sudden Cardiac Death, Cardiac Arrest, Emergency Service, Emergency Department, Ambulatory Electrocardiography, Holter, Holter Electrocardiography, Holter Monitoring
- Medical subject headings
- Syncope, Death, Sudden, Cardiac, Heart Arrest, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Term Wearable DefibrillatorDevice
Short-term Wearable Defibrillator (SWD 1000)
| Study group | Role | What they receive |
|---|---|---|
| SWD 1000 | Experimental | Short Term Wearable Defibrillator Receives: Device: Short Term Wearable Defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Unable to Monitor Due to ECG Noise
% time the device detected noise on both leads at the same time.
Measured: enrollment to 30 days
Device Monitoring Using Only One ECG Lead
% time that the device is monitoring using only one lead due to noise detected on the other lead
Measured: enrollment to 30 days
Followup Care Visits
Followup care for syncope - outpatient medical care visits
Measured: enrollment to 30 days
ER or Hospitalization
Followup care for syncope - returned to ER or admitted to hospital
Measured: enrollment to 30 days
Secondary outcomes (1)
Duration of Use
Average time the SWD 1000 was used by participants
Measured: enrollment to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SyncopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Szymkiewicz, MD, Study director, Zoll Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188147
- Sponsor's protocol ID
- 90D0119
- Acronym
- ASAP
- Status last verified
- Jan 2023
- First submitted
- 9 Jul 2014
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study Protocol
- ClinicalTrials.gov ID
- NCT02188147
- Acronym / sponsor ID
- ASAP / 90D0119
- Conditions
- Syncope
- Keywords
- Syncope, Sudden Cardiac Arrest, Sudden Cardiac Death, Cardiac Arrest, Emergency Service, Emergency Department, Ambulatory Electrocardiography, Holter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2014 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SWD 1000 | Experimental | Device: Short Term Wearable DefibrillatorShort Term Wearable Defibrillator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age≥18
- Experienced a syncopal event within the past 48 hours
- Either one of the following profiles(A or B) apply:
- 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
Key exclusion criteria (10 listed)
- 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:
- 6. Physical or mental conditions preventing subjects from interacting with or wearing the device as determined by the investigating physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Term Wearable DefibrillatorShort-term Wearable Defibrillator (SWD 1000) | Device | SWD 1000 |
Primary outcome
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.
Device Monitoring Using Only One ECG Lead
Time frame: enrollment to 30 days
% time that the device is monitoring using only one lead due to noise detected on the other lead
Followup Care Visits
Time frame: enrollment to 30 days
Followup care for syncope - outpatient medical care visits
ER or Hospitalization
Time frame: enrollment to 30 days
Followup care for syncope - returned to ER or admitted to hospital
1 secondary outcome
Duration of Use
Time frame: enrollment to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Szymkiewicz, MD study director
Zoll Medical Corporation
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Term Wearable Defibrillator in people with Syncope, run by Zoll Medical Corporation at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Unable to Monitor Due to ECG Noise (time frame: enrollment to 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.