N/A
N=59
Hospital Wearable Defibrillator Inpatient Study
In-Hospital Cardiac Arrest
Bottom Line
View on ClinicalTrials.gov: NCT02122549 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise. — 0.53; 2.54 percentage of time worn
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HWD1000 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zoll Medical Corporation
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise. |
0.53; 2.54 | — |
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.
Eligibility Criteria
Inclusion Criteria
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).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02122549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.