Sudden Cardiac Arrest
Conditions
Brief summary
Active surveillance study using real-world data collected in the ASSURE Patient Registry. Outcome measures are based on analysis of ASSURE Registry data including data recorded by the WCD then annotated by clinical experts in electrophysiology.
Interventions
DEVICEDefibrillation
External defibrillation from a wearable cardioverter defibrillator
Sponsors
Kestra Medical Technologies, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Adult patient prescribed the ASSURE wearable cardioverter defibrillator * Provided written informed consent to participate in the ASSURE Patient Registry
Exclusion criteria
* Patients who do not meet the Inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall shock conversion rate | Up to 3 years | Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) successfully converted with one or more shocks ≥ 89.0% |
| Inappropriate shocks per patient month | Up to 3 years | Total inappropriate shocks/cumulative months of WCD use for all patients ≤ 0.0075 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First shock conversion rate | Up to 3 years | Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) converted with a single shock. (report only) |
| Inappropriate shock rate | Up to 3 years | Percent of patients who experience at least one inappropriate shock (report only) |
Other
| Measure | Time frame | Description |
|---|---|---|
| False positive shock alarm rate | Up to 3 years | Number of false positive shock alarms/cumulative WCD use |
| True positive shock alarm rate | Up to 3 years | Number of true positive shock alarms/cumulative WCD use |
| Appropriate shock rate per month | Up to 3 years | Number of appropriate shocks/cumulative months of WCD use |
| Average daily device use | Up to 3 years | Average daily use of the WCD in hours per day |
| Cumulative device use | Up to 3 years | Cumulative device use in days |
| Adverse events | Up to 3 years | Adverse events related to use of the WCD |
| Appropriate shock rate | Up to 3 years | Percent of patients who experience at least one appropriate shock |
| Total Shocks delivered | Up to 3 years | Number of shocks delivered |
| Shocks diverted | Up to 3 years | Number of shocks diverted by patients |
Countries
United States
Contacts
Primary ContactKristin Eis, BSChE, MBA
Outcome results
None listed