Trial Outcomes & Findings for ASSURE WCD Clinical Evaluation - Detection and Safety Study (NCT NCT03887052)
NCT ID: NCT03887052
Last Updated: 2024-03-12
Results Overview
False Shock Alarms per patient day
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
130 participants
Primary outcome timeframe
30 days
Results posted on
2024-03-12
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
130
|
|
Overall Study
COMPLETED
|
121
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Motor Vehicle Accident, unrelated to study participation
|
1
|
|
Overall Study
Subject Hospitalized, unrelated to study participation
|
1
|
Baseline Characteristics
ASSURE WCD Clinical Evaluation - Detection and Safety Study
Baseline characteristics by cohort
| Measure |
Study Arm
n=130 Participants
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
|
|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 11.4 • n=39 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
124 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
83 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
130 participants
n=39 Participants
|
|
Indication for ICD
Primary Prevention
|
105 Participants
n=39 Participants
|
|
Indication for ICD
Secondary prevention, resuscitated, sudden cardiac arrest
|
14 Participants
n=39 Participants
|
|
Indication for ICD
Secondary prevention, symptomatic, sustained VT
|
9 Participants
n=39 Participants
|
|
Indication for ICD
Secondary prevention, inducible, sustained VT/VF during EP study
|
1 Participants
n=39 Participants
|
|
Indication for ICD
Secondary prevention, syncope attributable to VT/VF
|
1 Participants
n=39 Participants
|
|
Cardiomyopathy (Primary)
Ischemic
|
75 Participants
n=39 Participants
|
|
Cardiomyopathy (Primary)
Nonischemic (not primarily valvular)
|
44 Participants
n=39 Participants
|
|
Cardiomyopathy (Primary)
Mixed ischemic/nonischemic
|
1 Participants
n=39 Participants
|
|
Cardiomyopathy (Primary)
Primary valvular
|
2 Participants
n=39 Participants
|
|
Cardiomyopathy (Primary)
Arrhythmogenic right ventricular cardiomyopathy (ARVC)
|
0 Participants
n=39 Participants
|
|
Cardiomyopathy (Primary)
Hypertrophic cardiomyopathy
|
3 Participants
n=39 Participants
|
|
Cardiomyopathy (Primary)
Congenital
|
0 Participants
n=39 Participants
|
|
Cardiomyopathy (Primary)
Sarcoidosis
|
0 Participants
n=39 Participants
|
|
Cardiomyopathy (Primary)
Other
|
5 Participants
n=39 Participants
|
|
Primary Electrical Disorder
|
0 Participants
n=39 Participants
|
|
Left Ventricular Ejection Fraction
|
28.2 %
STANDARD_DEVIATION 7.1 • n=39 Participants
|
|
Comorbidities
Hypertension
|
96 Participants
n=39 Participants
|
|
Comorbidities
History of Heart Failure (HF)
|
125 Participants
n=39 Participants
|
|
Comorbidities
History of Coronary Artery Disease
|
95 Participants
n=39 Participants
|
|
Comorbidities
Diabetes
|
41 Participants
n=39 Participants
|
|
Comorbidities
Chronic Obstructive Pulmonary Disease (COPD)
|
28 Participants
n=39 Participants
|
|
Comorbidities
Chronic Kidney Disease
|
31 Participants
n=39 Participants
|
|
Body Mass Index
|
31.4 kg/m^2
STANDARD_DEVIATION 5.9 • n=39 Participants
|
|
NYHA Classification
I
|
9 Participants
n=39 Participants
|
|
NYHA Classification
II
|
52 Participants
n=39 Participants
|
|
NYHA Classification
III
|
43 Participants
n=39 Participants
|
|
NYHA Classification
IV
|
2 Participants
n=39 Participants
|
|
NYHA Classification
Unknown
|
19 Participants
n=39 Participants
|
|
NYHA Classification
Unclassified
|
5 Participants
n=39 Participants
|
|
Arrhythmia History
Prior ICD-detected VT/VF
|
71 Participants
n=39 Participants
|
|
Arrhythmia History
Atrial Fibrillation/flutter
|
51 Participants
n=39 Participants
|
|
Arrhythmia History
Bradycardia requiring pacing support
|
9 Participants
n=39 Participants
|
|
Arrhythmia History
Previous LifeVest use
|
21 Participants
n=39 Participants
|
|
QRS duration
|
113.8 msec
STANDARD_DEVIATION 24.7 • n=39 Participants
|
|
Current smoker
|
23 Participants
n=39 Participants
|
|
Baseline Medications
ACE Inhibitors
|
49 Participants
n=39 Participants
|
|
Baseline Medications
Beta Blockers
|
127 Participants
n=39 Participants
|
|
Baseline Medications
Angiotensin II Receptor Blocker (ARB)
|
25 Participants
n=39 Participants
|
|
Baseline Medications
Aldosterone Antagonist
|
52 Participants
n=39 Participants
|
|
Baseline Medications
Combination Drug
|
47 Participants
n=39 Participants
|
|
Baseline Medications
Digoxin
|
14 Participants
n=39 Participants
|
|
Baseline Medications
Antiarrhythmic Drugs
|
31 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: All enrolled subjects
False Shock Alarms per patient day
Outcome measures
| Measure |
Study Arm
n=130 Participants
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
|
|---|---|
|
WCD False Positive Alarm Rate
|
0.00075 false positive shock alarms per pt-day
Interval 0.00015 to 0.00361
|
SECONDARY outcome
Timeframe: 30 daysPopulation: All enrolled subjects
WCD recorded episodes annotated as VT or VF
Outcome measures
| Measure |
Study Arm
n=130 Participants
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
|
|---|---|
|
WCD True Positive Detections
|
4 true positive detections
|
SECONDARY outcome
Timeframe: 30 daysPopulation: All enrolled subjects
WCD False Negative Detections
Outcome measures
| Measure |
Study Arm
n=130 Participants
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
|
|---|---|
|
WCD Missed Events
|
0 WCD false negative detections
|
Adverse Events
Study Arm
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Study Arm
n=129 participants at risk
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
|
|---|---|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
22.5%
29/129 • Number of events 34 • During the period each patient wore the WCD, median 31.0 days
Adverse Events (AEs) were defined as any untoward medical occurrence in a subject during the study that in the opinion of the investigator was at least possibly related to use of the ASSURE system. The Per Protocol cohort (n=129) included all subjects in the Intent-to-Treat cohort except one who was found to be ineligible soon after enrollment and immediately withdrawn. This subject was also excluded from the Safety cohort (n=129) because the subject did not wear the WCD for at least two hours.
|
Additional Information
Laura Gustavson, VP Clinical Marketing
Kestra Medical Technologies, Inc.
Phone: 14255264759
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No less than one month prior to public disclosure of any results of the Project, Investigator will provide Kestra a manuscript or other draft of the proposed public disclosure. Within one month following receipt thereof, Kestra will notify Investigator in writing if the proposed disclosure contains any Kestra Confidential Information or substantial duplications of the written reports provided and specify the portions of the proposed disclosure requiring redactions or other modifications.
- Publication restrictions are in place
Restriction type: OTHER