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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HWD1000 | Experimental | Subjects using HWD1000 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HWD1000 | Device | Wearable cardioverter-defibrillator designed for inpatient use |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 hours or longer |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven J Szymkiewicz, MD | Zoll Medical Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | HWD1000 | Subjects using HWD1000 HWD1000: Wearable cardioverter-defibrillator designed for inpatient use |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Hospitalized patients at risk for sudden cardiac arrest.
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| ID | Title | Description |
|---|---|---|
| BG000 | HWD1000 | Subjects using HWD1000 HWD1000: Wearable cardioverter-defibrillator designed for inpatient use |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Subjects who wore the HWD 1000 for a minimum of 24 hours. | Posted | Mean | Standard Deviation | percentage of time worn | 24 hours or longer |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HWD1000 | Subjects using HWD1000 HWD1000: Wearable cardioverter-defibrillator designed for inpatient use |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Iritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Medical Affairs | ZOLL | 412-968-3333 | 14400 | stevens@zoll.com |
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| Danbury |
| Connecticut |
| United States |
| Atlantis | Florida | United States |
| Jupiter | Florida | United States |
| Iowa City | Iowa | United States |
| Saint Paul | Minnesota | United States |
| Richmond | Virginia | United States |
| Seattle | Washington | United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
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| 0 |
| 59 |
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| 59 |
| 0 |
| 59 |
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