CClinicalTrials.gg
Sign In
CompletedNCT02188147ASAPUpdated Feb 21, 2023Results posted

Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study

An interventional study of Short Term Wearable Defibrillator in Syncope, sponsored by Zoll Medical Corporation. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by Zoll Medical Corporation · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Syncope

Browse trials for

Keywords

  • Syncope
  • Sudden Cardiac Arrest
  • Sudden Cardiac Death
  • Cardiac Arrest
  • Emergency Service
  • Emergency Department
  • Ambulatory Electrocardiography
  • Holter
  • Holter Electrocardiography
  • Holter Monitoring
03

In context

Syncope

226 studies on the registry are indexed under Syncope; 45 are open to participants now.

This study's enrollment of 39 is below the median of 79 across 126 interventional studies indexed under Syncope.

Browse Syncope studies →

Lead sponsor

Zoll Medical Corporation is the lead sponsor of 34 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
  1. Physical or mental conditions preventing subjects from interacting with or wearing the device as determined by the investigating physician.
  1. 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    SWD 1000

    Short Term Wearable Defibrillator

    Device: Short Term Wearable Defibrillator

Interventions

  • DeviceShort Term Wearable Defibrillator

    Short-term Wearable Defibrillator (SWD 1000)

06

What researchers measure

Primary outcomes

  1. Device Unable to Monitor Due to ECG Noise

    % time the device detected noise on both leads at the same time.

    Time frame: enrollment to 30 days

  2. 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

    Time frame: enrollment to 30 days

  3. Followup Care Visits

    Followup care for syncope - outpatient medical care visits

    Time frame: enrollment to 30 days

  4. ER or Hospitalization

    Followup care for syncope - returned to ER or admitted to hospital

    Time frame: enrollment to 30 days

Secondary outcomes

  1. Duration of Use

    Average time the SWD 1000 was used by participants

    Time frame: enrollment to 30 days

07

Results

Posted Feb 21, 2023

Participant flow

Participant flow — Overall Study
MilestoneSWD 1000
Started39
Completed39
Not completed0

Outcome measures

PrimaryDevice Unable to Monitor Due to ECG Noise

% time the device detected noise on both leads at the same time.

Time frame:
enrollment to 30 days
Reported as:
Mean · percentage of time worn
Device Unable to Monitor Due to ECG Noise
percentage of time wornSWD 1000
Device Unable to Monitor Due to ECG Noise1.5 (0.59 to 2.39)
PrimaryDevice Monitoring Using Only One ECG Lead

% time that the device is monitoring using only one lead due to noise detected on the other lead

Time frame:
enrollment to 30 days
Reported as:
Mean · percentage of time worn
Device Monitoring Using Only One ECG Lead
percentage of time wornSWD 1000
Device Monitoring Using Only One ECG Lead2.5 (2.44 to 4.18)
PrimaryFollowup Care Visits

Followup care for syncope - outpatient medical care visits

Time frame:
enrollment to 30 days
Reported as:
Count of participants · Participants
Followup Care Visits
ParticipantsSWD 1000
Followup Care Visits17
PrimaryER or Hospitalization

Followup care for syncope - returned to ER or admitted to hospital

Time frame:
enrollment to 30 days
Reported as:
Count of participants · Participants
ER or Hospitalization
ParticipantsSWD 1000
ER or Hospitalization4
SecondaryDuration of Use

Average time the SWD 1000 was used by participants

Time frame:
enrollment to 30 days
Reported as:
Mean · days
Duration of Use
daysSWD 1000
Duration of Use6.1 ± 5.2
Post-hocNoise Alarms

SWD 1000 alarms given to alert user of detected noise on one or more ECG leads

Time frame:
enrollment to 30 days
Reported as:
Mean · count of alarms per subject
Noise Alarms
count of alarms per subjectSWD 1000
Noise Alarms15 ± 17
Post-hocArrhythmia Alarms

Device alarms given because an arrhythmia was detected (may or may not be real arrhythmia)

Time frame:
enrollment to 30 days
Reported as:
Mean · number of alarms per subjects
Arrhythmia Alarms
number of alarms per subjectsSWD 1000
Arrhythmia Alarms9.9 ± 31.1

Adverse events

Collected over 30 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SWD 10000/39 (0%)0/39 (0%)13/39 (33.3%)
Most frequent other events
Most frequent other events
EventSWD 1000
Skin rash or irritationSkin and subcutaneous tissue disorders10/39
Inappropriate shockInjury, poisoning and procedural complications3/39

Baseline characteristics

Age, Continuous
Age, Continuous(years)SWD 1000
Mean44.4 ± 17.8
Sex: Female, Male
Sex: Female, Male(Participants)SWD 1000
Female15
Male24
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SWD 1000
Hispanic or Latino0
Not Hispanic or Latino0
Unknown or Not Reported39
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SWD 1000
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White0
More than one race0
Unknown or Not Reported39
Height
Height(inches)SWD 1000
Mean67.5 ± 3.8
Weight
Weight(pounds)SWD 1000
Mean185.2 ± 51.6
Blood pressure
Blood pressure(mm Hg)SWD 1000
Systolic127 ± 18
Diastolic76 ± 13
Heart rate
Heart rate(beats per minute)SWD 1000
Mean76 ± 15

9 further baseline measures are reported on the registry.

08

Study locations

6 sites
  • Danbury, Connecticut, United States
  • Jacksonville, Florida, United States
  • Minneapolis, Minnesota, United States
  • Saint Paul, Minnesota, United States
  • Staten Island, New York, United States
  • Cincinnati, Ohio, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 15, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02188147
Lead sponsor
Zoll Medical Corporation
Responsible party
Sponsor
First posted
Jul 11, 2014
Start date
Aug 2014
Primary completion
Apr 2020
Completion
Apr 15, 2020
Results posted
Feb 21, 2023
Last update
Feb 21, 2023

Study contacts

Steve Szymkiewicz, MD
study director · Zoll Medical Corporation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Syncope→

Other studies from this sponsor

Zoll Medical Corporation

Start the discussion