In-Hospital Cardiac ArrestHWDNCT02122549

Hospital Wearable Defibrillator Inpatient Study

A study testing HWD1000 in people with In-Hospital Cardiac Arrest, run by Zoll Medical Corporation at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will obtain device-human interaction evaluations for the HWD1000 within the controlled environment of the hospital as well as establish that the safety profile is similar to outpatient wearable cardioverter-defibrillators use. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: In-Hospital Cardiac Arrest
What is being tested?: HWD1000
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 8 sitesUnited States
Study dates: Apr 2014to Jul 2015
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

Patients whom a physician deems at risk of sudden cardiac arrest during the hospitalization period (patients will be monitored using the hospital's telemetry system). Specific inclusion criteria are:
Hospitalized patients having continuous independent ECG monitoring.
Patients at risk of sudden cardiac arrest during the hospitalization period as determined by the investigating physician.
Patient ≥18 years of age (over the legal age of providing consent).

Who cannot join

Patients with an active implantable cardioverter-defibrillator.
Patients with an active unipolar pacemaker.
Patients with physical or mental conditions preventing them from interacting with or wearing the device as determined by the investigating physician.
Patients having an advanced directive prohibiting resuscitation.
Patients having bandages or other clinical condition preventing the HWD use.
Patients unable to consent.
Patients having recently experienced an arrhythmic storm.
Patients prone to paroxysmal supraventricular tachycardia.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Study site
Atlantis, Florida
Study site
Danbury, Connecticut
Study site
Iowa City, Iowa
Study site
Jupiter, Florida
Study site
Los Angeles, California
Study site
Richmond, Virginia
Study site
Saint Paul, Minnesota
Study site
Seattle, Washington

Other trials in United States

About this study

Read the detailed description

A multi-center prospective study of hospitalized patients whom a physician deems at risk of sudden cardiac arrest during the hospitalization period, wearing the HWD1000 hospital wearable defibrillator in order to evaluate caregiver and patient interactions with the device. In addition, ECG signal quality will be reviewed to confirm the HWD1000 safety profile.

Conditions: In-Hospital Cardiac Arrest
Being tested: HWD1000
Keywords: In-Hospital Cardiac Arrest, Telemetry

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HWD1000Device
Wearable cardioverter-defibrillator designed for inpatient use

Study groups in NCT02122549
Study group	Role	What they receive
HWD1000	Experimental	Subjects using HWD1000 Receives: Device: HWD1000

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise.
The amount of time that the HWD1000 is unable to monitor the subject's rhythm status is the primary safety measure. The specific goals are that average monitoring will be inhibited by noise no greater than 2% of the time worn (at least 24 hours) and monitoring using single lead analysis will be no greater than 5% of the time worn (at least 24 hours).
Measured: 24 hours or longer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Jul 2015

First posted24 Apr 2014 (estimated)
Study startApr 2014
Primary completionJul 2015
Study completionJul 2015

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 In-Hospital Cardiac ArrestStudies 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: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02122549
Sponsor's protocol ID: 90D0118
Acronym: HWD
Status last verified: Feb 2017
First submitted: 17 Apr 2014
Last updated: 31 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
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The Danish Out-of-Hospital Cardiac Arrest Study
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Compression-Only Versus Standard Basic Life Support Training in Nursing Students
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Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
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The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital

All In-Hospital Cardiac Arrest trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hospital Wearable Defibrillator Inpatient Study
ClinicalTrials.gov ID: NCT02122549
Acronym / sponsor ID: HWD / 90D0118
Conditions: In-Hospital Cardiac Arrest
Keywords: In-Hospital Cardiac Arrest, Telemetry
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: Zoll Medical CorporationIndustry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 24 Apr 2014 (estimated)
Results: Posted 31 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
HWD1000	Experimental	Device: HWD1000Subjects using HWD1000

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients whom a physician deems at risk of sudden cardiac arrest during the hospitalization period (patients will be monitored using the hospital's telemetry system). Specific inclusion criteria are:
Hospitalized patients having continuous independent ECG monitoring.
Patients at risk of sudden cardiac arrest during the hospitalization period as determined by the investigating physician.
Patient ≥18 years of age (over the legal age of providing consent).

Key exclusion criteria (8 listed)

Patients with an active implantable cardioverter-defibrillator.
Patients with an active unipolar pacemaker.
Patients with physical or mental conditions preventing them from interacting with or wearing the device as determined by the investigating physician.
Patients having an advanced directive prohibiting resuscitation.
Patients having bandages or other clinical condition preventing the HWD use.

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
HWD1000Wearable cardioverter-defibrillator designed for inpatient use	Device	HWD1000

Primary outcome

Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise.
Time frame: 24 hours or longer
The amount of time that the HWD1000 is unable to monitor the subject's rhythm status is the primary safety measure. The specific goals are that average monitoring will be inhibited by noise no greater than 2% of the time worn (at least 24 hours) and monitoring using single lead analysis will be no greater than 5% of the time worn (at least 24 hours).

Results and safety

Results posted to the registry on 31 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HWD1000	59	59

Primary outcome: Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise.

Time frame: 24 hours or longer. Mean (Standard Deviation). Unit: percentage of time worn

Measure	HWD1000 n = 38
Neither lead used for monitoring	0.53 (0.73)
One lead not used for monitoring	2.54 (3.16)

Population analysed: Subjects who wore the HWD 1000 for a minimum of 24 hours.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HWD1000	0 of 59 (0%)	0 of 59 (0%)	0 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for In-Hospital Cardiac Arrest

Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital

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.

Steven J Szymkiewicz, MD principal investigator

Zoll Medical Corporation

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HWD1000 in people with In-Hospital Cardiac Arrest, run by Zoll Medical Corporation at 8 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 4 inclusion and 8 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 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 31 May 2017). 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?

Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise. (time frame: 24 hours or longer). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02122549.

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 31 May 2017.