Cardiac Arrest, Sudden
Conditions
Brief summary
A prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the ASSURE™ Wearable Cardioverter Defibrillator (WCD).
Detailed description
A prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the ASSURE™ Wearable Cardioverter Defibrillator (WCD). A total of 130 adult subjects at risk for sudden cardiac arrest but otherwise protected by an Implantable Cardioverter Defibrillator (ICD) will be enrolled at 10 clinical sites in the United States. Subjects will wear the device for approximately 30 days during normal daily activities including sleep. The WCD shock alarms and shock functionality will be disabled. Shock Alarm Event Markers are recorded by the WCD and will be used for analysis of the primary outcome measure. All episodes recorded by the ASSURE WCD and/or the subject's ICD will be reviewed by independent clinical experts.
Interventions
DEVICEASSURE™ Wearable Cardioverter Defibrillator (WCD)
WCD with shock alarms and shock functionality disabled
Sponsors
Regulatory and Clinical Research Institute Inc
Kestra Medical Technologies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Multicenter single arm open label evaluation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males or females, age ≥ 18 years 2. Patients with an active Implantable Cardioverter Defibrillator (ICD) 3. Left Ventricular Ejection Fraction (LVEF) ≤ 40%, measured within the past year (12 months) by echocardiography, nuclear imaging (including MRI), or left ventricular angiography 4. Able and willing to provide written informed consent before undergoing any study-related procedures
Exclusion criteria
1. Any condition that by the judgement of the physician investigator precludes the subject's ability to comply with the study requirements, including cognitive and/or physical limitations that would prevent the subject from interacting with the device as intended 2. Any known skin allergy or sensitivity to the study garment materials that will be next to the skin 3. Any breached or compromised skin on the upper body that would be exacerbated by wearing the study garment 4. Work with or are frequently around equipment that produces high electromagnetic fields, for example magnetic resonance imaging devices, power supply facilities, or welding equipment 5. Any planned surgical or medical procedures during the participation period that would require the subject to remove the study device for more than 12 hours 6. Any planned air travel during the participation period 7. Pregnancy 8. Use of mechanical circulatory support, including but not limited to Left Ventricular Assist Device (LVAD) or Total Artificial Heart 9. Implanted Cardiac Resynchronization Therapy Defibrillator (CRT-D) 10. Simultaneous plan/prescription for Holter monitor, mobile cardiac outpatient telemetry (MCOT), Event Recorder, or in-hospital telemetry 11. Use of any electronic medical device that is worn on or near the body requires Sponsor approval, other than continuous positive airway pressure (CPAP), continuous blood glucose monitor, or pulse oximeter oxygen saturation (SpO2) monitor. 12. Under bust chest circumference greater than 52 inches or less than 28 inches 13. Current hospital inpatient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WCD False Positive Alarm Rate | 30 days | False Shock Alarms per patient day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WCD True Positive Detections | 30 days | WCD recorded episodes annotated as VT or VF |
| WCD Missed Events | 30 days | WCD False Negative Detections |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Arm Adult cardiac patients at risk for sudden cardiac arrest otherwise protected with an Implantable Cardioverter Defibrillator (ICD)
ASSURE™ Wearable Cardioverter Defibrillator (WCD): WCD with shock alarms and shock functionality disabled | 130 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Motor Vehicle Accident, unrelated to study participation | 1 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Subject Hospitalized, unrelated to study participation | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Study Arm |
|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 11.4 |
| Arrhythmia History Atrial Fibrillation/flutter | 51 Participants |
| Arrhythmia History Bradycardia requiring pacing support | 9 Participants |
| Arrhythmia History Previous LifeVest use | 21 Participants |
| Arrhythmia History Prior ICD-detected VT/VF | 71 Participants |
| Baseline Medications ACE Inhibitors | 49 Participants |
| Baseline Medications Aldosterone Antagonist | 52 Participants |
| Baseline Medications Angiotensin II Receptor Blocker (ARB) | 25 Participants |
| Baseline Medications Antiarrhythmic Drugs | 31 Participants |
| Baseline Medications Beta Blockers | 127 Participants |
| Baseline Medications Combination Drug | 47 Participants |
| Baseline Medications Digoxin | 14 Participants |
| Body Mass Index | 31.4 kg/m^2 STANDARD_DEVIATION 5.9 |
| Cardiomyopathy (Primary) Arrhythmogenic right ventricular cardiomyopathy (ARVC) | 0 Participants |
| Cardiomyopathy (Primary) Congenital | 0 Participants |
| Cardiomyopathy (Primary) Hypertrophic cardiomyopathy | 3 Participants |
| Cardiomyopathy (Primary) Ischemic | 75 Participants |
| Cardiomyopathy (Primary) Mixed ischemic/nonischemic | 1 Participants |
| Cardiomyopathy (Primary) Nonischemic (not primarily valvular) | 44 Participants |
| Cardiomyopathy (Primary) Other | 5 Participants |
| Cardiomyopathy (Primary) Primary valvular | 2 Participants |
| Cardiomyopathy (Primary) Sarcoidosis | 0 Participants |
| Comorbidities Chronic Kidney Disease | 31 Participants |
| Comorbidities Chronic Obstructive Pulmonary Disease (COPD) | 28 Participants |
| Comorbidities Diabetes | 41 Participants |
| Comorbidities History of Coronary Artery Disease | 95 Participants |
| Comorbidities History of Heart Failure (HF) | 125 Participants |
| Comorbidities Hypertension | 96 Participants |
| Current smoker | 23 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 124 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Indication for ICD Primary Prevention | 105 Participants |
| Indication for ICD Secondary prevention, inducible, sustained VT/VF during EP study | 1 Participants |
| Indication for ICD Secondary prevention, resuscitated, sudden cardiac arrest | 14 Participants |
| Indication for ICD Secondary prevention, symptomatic, sustained VT | 9 Participants |
| Indication for ICD Secondary prevention, syncope attributable to VT/VF | 1 Participants |
| Left Ventricular Ejection Fraction | 28.2 % STANDARD_DEVIATION 7.1 |
| NYHA Classification I | 9 Participants |
| NYHA Classification II | 52 Participants |
| NYHA Classification III | 43 Participants |
| NYHA Classification IV | 2 Participants |
| NYHA Classification Unclassified | 5 Participants |
| NYHA Classification Unknown | 19 Participants |
| Primary Electrical Disorder | 0 Participants |
| QRS duration | 113.8 msec STANDARD_DEVIATION 24.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 83 Participants |
| Region of Enrollment United States | 130 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 129 |
| other Total, other adverse events | 29 / 129 |
| serious Total, serious adverse events | 0 / 129 |
Outcome results
Primary
WCD False Positive Alarm Rate
False Shock Alarms per patient day
Time frame: 30 days
Population: All enrolled subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Arm | WCD False Positive Alarm Rate | 0.00075 false positive shock alarms per pt-day |
Comparison: The analysis was based on the cohort of 130 patients with three false-positive shock alarms occurring over a total of 3501 patient-days (500 weeks), or 0.0060 false-positive shock alarms per patient-week. The Poisson distribution was used to model the results and calculate the false-positive shock alarm rate.p-value: <0.001One-sided non-inferiority
Secondary
WCD Missed Events
WCD False Negative Detections
Time frame: 30 days
Population: All enrolled subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Arm | WCD Missed Events | 0 WCD false negative detections |
Secondary
WCD True Positive Detections
WCD recorded episodes annotated as VT or VF
Time frame: 30 days
Population: All enrolled subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Arm | WCD True Positive Detections | 4 true positive detections |