Trial Outcomes & Findings for Heart Failure Optimization Study (NCT NCT03016754)
NCT ID: NCT03016754
Last Updated: 2025-03-24
Results Overview
The percentage of patients reaching the goal of LVEF\>35% will be compared at 90 days and 180 days. Echocardiographic assessment of LVEF was used.
Recruitment status
COMPLETED
Target enrollment
602 participants
Primary outcome timeframe
180 days
Results posted on
2025-03-24
Participant Flow
Patients were initially screened from the prescribed wearable cardioverter defibrillator (WCD) patients and enrolled into a pre-study registry (n=1300). At 90 +/- 14 days of WCD use, patients were screened from the site's pre-study registry participants. Subjects determined to be ineligible for the study or those exiting the registry before study phase were excluded (n=698). The study phase started at day 90.
Participant milestones
| Measure |
Early Recovery
Patients improved to LVEF \>35% within the first 90 days following guideline directed medical therapy (GDMT). These patients are expected to end wearable cardioverter defibrillator (WCD) use and not receive an implantable cardioverter defibrillator (ICD) according to current guidelines.
|
Improvement
Patients improved LVEF from start of WCD use (a positive change of at least 5% in LVEF) or have borderline LVEF of 30-35% at day 90. These patients were expected, but not required to continue to use the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Non-improvement
Patients show no change, worsening of LVEF or LVEF \<30%. Those on guideline directed medical therapy (GDMT) are expected to be evaluated for an implantable cardioverter defibrillator (ICD). Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Unassigned Based on Left Ventricular Ejection Fraction (LVEF)
Study subjects missing a day 90 LVEF value and were unable to be assigned to a group.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
279
|
214
|
90
|
19
|
|
Overall Study
COMPLETED
|
243
|
183
|
77
|
9
|
|
Overall Study
NOT COMPLETED
|
36
|
31
|
13
|
10
|
Reasons for withdrawal
| Measure |
Early Recovery
Patients improved to LVEF \>35% within the first 90 days following guideline directed medical therapy (GDMT). These patients are expected to end wearable cardioverter defibrillator (WCD) use and not receive an implantable cardioverter defibrillator (ICD) according to current guidelines.
|
Improvement
Patients improved LVEF from start of WCD use (a positive change of at least 5% in LVEF) or have borderline LVEF of 30-35% at day 90. These patients were expected, but not required to continue to use the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Non-improvement
Patients show no change, worsening of LVEF or LVEF \<30%. Those on guideline directed medical therapy (GDMT) are expected to be evaluated for an implantable cardioverter defibrillator (ICD). Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Unassigned Based on Left Ventricular Ejection Fraction (LVEF)
Study subjects missing a day 90 LVEF value and were unable to be assigned to a group.
|
|---|---|---|---|---|
|
Overall Study
Death
|
5
|
4
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
23
|
17
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
2
|
2
|
|
Overall Study
Other/Unknown
|
2
|
4
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
4
|
Baseline Characteristics
Heart Failure Optimization Study
Baseline characteristics by cohort
| Measure |
Early Recovery
n=279 Participants
Patients improved to LVEF \>35% within the first 90 days following guideline directed medical therapy (GDMT). These patients are expected to end WCD use and not receive an implantable cardioverter defibrillator according to current guidelines.
|
Improvement
n=214 Participants
Patients improved LVEF from start of WCD use (a positive change of at least 5% in LVEF) or have borderline LVEF of 30-35% at day 90. These patients were expected, but not required to continue to use the WCD for an additional 90 days.
|
Non-improvement
n=90 Participants
Patients show no change, worsening of LVEF or LVEF \<30%. Those on guideline directed medical therapy (GDMT) are expected to be evaluated for an implantable cardioverter defibrillator. Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days.
|
Unassigned Based on Left Ventricular Ejection Fraction (LVEF)
n=19 Participants
Study subjects missing a day 90 LVEF value and were unable to be assigned to a group.
|
Total
n=602 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 13 • n=5 Participants
|
57 years
STANDARD_DEVIATION 14 • n=7 Participants
|
60 years
STANDARD_DEVIATION 13 • n=5 Participants
|
58 years
STANDARD_DEVIATION 11 • n=4 Participants
|
59 years
STANDARD_DEVIATION 13 • n=21 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
164 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
191 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
438 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian or Alaskan native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
231 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
484 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic or Latin
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
31 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · No response
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Multiple races selected
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
Austria
|
10 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
16 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
151 participants
n=5 Participants
|
115 participants
n=7 Participants
|
57 participants
n=5 Participants
|
8 participants
n=4 Participants
|
331 participants
n=21 Participants
|
|
Region of Enrollment
France
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
15 participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
115 participants
n=5 Participants
|
92 participants
n=7 Participants
|
30 participants
n=5 Participants
|
3 participants
n=4 Participants
|
240 participants
n=21 Participants
|
|
Body Mass Index (BMI)
|
30.0 kg/m^2
STANDARD_DEVIATION 7.4 • n=5 Participants
|
29.0 kg/m^2
STANDARD_DEVIATION 6.4 • n=7 Participants
|
29.8 kg/m^2
STANDARD_DEVIATION 7.2 • n=5 Participants
|
28.7 kg/m^2
STANDARD_DEVIATION 6.2 • n=4 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 7.0 • n=21 Participants
|
|
Systolic blood pressure
|
124 mmHg
STANDARD_DEVIATION 22 • n=5 Participants
|
116 mmHg
STANDARD_DEVIATION 19 • n=7 Participants
|
118 mmHg
STANDARD_DEVIATION 15 • n=5 Participants
|
124 mmHg
STANDARD_DEVIATION 20 • n=4 Participants
|
120 mmHg
STANDARD_DEVIATION 20 • n=21 Participants
|
|
History of hypertension (HTN)
|
196 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
386 Participants
n=21 Participants
|
|
History of diabetes
|
69 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
164 Participants
n=21 Participants
|
|
History of chronic obstructive pulmonary disease (COPD)
|
37 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
History of transient ischemic attack/Cerebrovascular accident
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
History of chronic kidney disease
|
29 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Ischemic cardiomyopathy
|
113 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
230 Participants
n=21 Participants
|
|
Non-ischemic cardiomyopathy
|
156 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
348 Participants
n=21 Participants
|
|
Mixed cardiomyopathy
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
History of sudden cardiac arrest
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
History of arrhythmia in past year
Atrial Flutter
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
History of arrhythmia in past year
Atrial fibrillation
|
68 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
|
History of arrhythmia in past year
Sinus tachycardia
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
|
History of arrhythmia in past year
Supraventricular tachycardia
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
History of arrhythmia in past year
Ventricular tachycardia
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
History of arrhythmia in past year
Ventricular fibrillation
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
History of arrhythmia in past year
Ventricular tachycardia (non-sustained
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
History of arrhythmia in past year
Sinus bradycardia
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
History of arrhythmia in past year
First-degree AV block
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
History of arrhythmia in past year
Type I Second-degree AV block
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
History of arrhythmia in past year
Type II Second-degree AV block
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
History of arrhythmia in past year
Third degree AV block
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
History of arrhythmia in past year
Paced rhythm
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Initial heart rate
|
80 Beats per minute
STANDARD_DEVIATION 17 • n=5 Participants
|
84 Beats per minute
STANDARD_DEVIATION 18 • n=7 Participants
|
85 Beats per minute
STANDARD_DEVIATION 16 • n=5 Participants
|
74 Beats per minute
STANDARD_DEVIATION 23 • n=4 Participants
|
82 Beats per minute
STANDARD_DEVIATION 18 • n=21 Participants
|
|
Initial respiration rate
|
17 Breaths per minute
STANDARD_DEVIATION 3 • n=5 Participants
|
17 Breaths per minute
STANDARD_DEVIATION 3 • n=7 Participants
|
17 Breaths per minute
STANDARD_DEVIATION 3 • n=5 Participants
|
16 Breaths per minute
STANDARD_DEVIATION 2 • n=4 Participants
|
17 Breaths per minute
STANDARD_DEVIATION 3 • n=21 Participants
|
|
History of myocardial infarction
|
66 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
129 Participants
n=21 Participants
|
|
History of coronary artery bypass graft surgery
|
25 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
History of percutaneous coronary intervention
|
71 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
134 Participants
n=21 Participants
|
|
New York Heart Association (NYHA) functional class at index hospitalization
Class I
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
New York Heart Association (NYHA) functional class at index hospitalization
Class II
|
56 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
|
New York Heart Association (NYHA) functional class at index hospitalization
Class III
|
100 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
224 Participants
n=21 Participants
|
|
New York Heart Association (NYHA) functional class at index hospitalization
Class IV
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
New York Heart Association (NYHA) functional class at index hospitalization
Not documented
|
85 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
183 Participants
n=21 Participants
|
|
New York Heart Association (NYHA) functional class at registry start
Class I
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
New York Heart Association (NYHA) functional class at registry start
Class II
|
85 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
184 Participants
n=21 Participants
|
|
New York Heart Association (NYHA) functional class at registry start
Class III
|
68 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
137 Participants
n=21 Participants
|
|
New York Heart Association (NYHA) functional class at registry start
Class IV
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
New York Heart Association (NYHA) functional class at registry start
Not documented
|
104 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
238 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 180 daysPopulation: Subjects with all three LVEF measurements (baseline, day 90, day 180) were analyzed.
The percentage of patients reaching the goal of LVEF\>35% will be compared at 90 days and 180 days. Echocardiographic assessment of LVEF was used.
Outcome measures
| Measure |
Early Recovery
n=222 Participants
Patients improved to LVEF \>35% within the first 90 days following guideline directed medical therapy (GDMT). These patients are expected to end WCD use and not receive an implantable cardioverter defibrillator according to current guidelines.
|
Improvement
n=186 Participants
Patients improved LVEF from start of WCD use (a positive change of at least 5% in LVEF) or have borderline LVEF of 30-35% at day 90. These patients were expected, but not required to continue to use the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Non-improvement
n=79 Participants
Patients show no change, worsening of LVEF or LVEF \<30%. Those on guideline directed medical therapy (GDMT) are expected to be evaluated for an implantable cardioverter defibrillator. Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Unassigned Based on Left Ventricular Ejection Fraction (LVEF)
Study subjects missing a day 90 LVEF value and were unable to be assigned to a group.
|
|---|---|---|---|---|
|
Percentage of Patients With LVEF Recovery at Day 90 and 180
Day 90 LVEF · Day 90 LVEF <=35%
|
0 Participants
|
186 Participants
|
79 Participants
|
—
|
|
Percentage of Patients With LVEF Recovery at Day 90 and 180
Day 180 LVEF · Day 90 LVEF >35%
|
208 Participants
|
97 Participants
|
25 Participants
|
—
|
|
Percentage of Patients With LVEF Recovery at Day 90 and 180
Day 90 LVEF · Day 90 LVEF >35%
|
222 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Percentage of Patients With LVEF Recovery at Day 90 and 180
Day 180 LVEF · Day 90 LVEF <=35%
|
14 Participants
|
89 Participants
|
54 Participants
|
—
|
PRIMARY outcome
Timeframe: 180 daysPopulation: Subjects with all three LVEF measurements (baseline, day 90, day 180) were analyzed.
Descriptive statistics will be used to assess the percentage of study subjects reaching target doses of GDMT at 90 and 180 days. All eligible study subjects with LVEF data at all three timepoints were used for this analysis.
Outcome measures
| Measure |
Early Recovery
n=222 Participants
Patients improved to LVEF \>35% within the first 90 days following guideline directed medical therapy (GDMT). These patients are expected to end WCD use and not receive an implantable cardioverter defibrillator according to current guidelines.
|
Improvement
n=186 Participants
Patients improved LVEF from start of WCD use (a positive change of at least 5% in LVEF) or have borderline LVEF of 30-35% at day 90. These patients were expected, but not required to continue to use the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Non-improvement
n=79 Participants
Patients show no change, worsening of LVEF or LVEF \<30%. Those on guideline directed medical therapy (GDMT) are expected to be evaluated for an implantable cardioverter defibrillator. Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Unassigned Based on Left Ventricular Ejection Fraction (LVEF)
Study subjects missing a day 90 LVEF value and were unable to be assigned to a group.
|
|---|---|---|---|---|
|
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Reached target dose mineralocorticoid receptor antagonist at Day 180 · Dose not available
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Reached target dose RAS antagonist at Day 90 · Target dose not reached
|
136 Participants
|
125 Participants
|
63 Participants
|
—
|
|
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Reached target dose RAS antagonist at Day 90 · Dose not available
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Reached target dose mineralocorticoid receptor antagonist at Day 90 · Target dose reached
|
114 Participants
|
77 Participants
|
30 Participants
|
—
|
|
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Reached target dose mineralocorticoid receptor antagonist at Day 90 · Target dose not reached
|
108 Participants
|
109 Participants
|
49 Participants
|
—
|
|
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Reached target dose mineralocorticoid receptor antagonist at Day 90 · Dose not available
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Reached target dose beta-blocker at Day 180 · Target dose reached
|
56 Participants
|
47 Participants
|
19 Participants
|
—
|
|
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Reached target dose beta-blocker at Day 180 · Target dose not reached
|
166 Participants
|
139 Participants
|
60 Participants
|
—
|
|
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Reached target dose beta-blocker at Day 180 · Dose not available
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Reached target dose RAS antagonist at Day 180 · Target dose reached
|
92 Participants
|
84 Participants
|
22 Participants
|
—
|
|
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Reached target dose RAS antagonist at Day 180 · Target dose not reached
|
130 Participants
|
101 Participants
|
56 Participants
|
—
|
|
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Reached target dose RAS antagonist at Day 180 · Dose not available
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Reached target dose mineralocorticoid receptor antagonist at Day 180 · Target dose reached
|
103 Participants
|
84 Participants
|
30 Participants
|
—
|
|
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Reached target dose mineralocorticoid receptor antagonist at Day 180 · Target dose not reached
|
119 Participants
|
102 Participants
|
49 Participants
|
—
|
|
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Reached target dose beta-blocker at Day 90 · Target dose reached
|
57 Participants
|
36 Participants
|
16 Participants
|
—
|
|
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Reached target dose beta-blocker at Day 90 · Target dose not reached
|
164 Participants
|
149 Participants
|
63 Participants
|
—
|
|
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Reached target dose beta-blocker at Day 90 · Dose not available
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
Reached target dose RAS antagonist at Day 90 · Target dose reached
|
86 Participants
|
59 Participants
|
16 Participants
|
—
|
SECONDARY outcome
Timeframe: 360 daysPopulation: Subjects consented and enrolled into the study phase at Day 90.
Observe the percentage of patients having sustained VT/VF arrhythmias during WCD use. As this was a secondary outcome to describe events during all WCD use, all eligible registry subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.
Outcome measures
| Measure |
Early Recovery
n=279 Participants
Patients improved to LVEF \>35% within the first 90 days following guideline directed medical therapy (GDMT). These patients are expected to end WCD use and not receive an implantable cardioverter defibrillator according to current guidelines.
|
Improvement
n=214 Participants
Patients improved LVEF from start of WCD use (a positive change of at least 5% in LVEF) or have borderline LVEF of 30-35% at day 90. These patients were expected, but not required to continue to use the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Non-improvement
n=90 Participants
Patients show no change, worsening of LVEF or LVEF \<30%. Those on guideline directed medical therapy (GDMT) are expected to be evaluated for an implantable cardioverter defibrillator. Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Unassigned Based on Left Ventricular Ejection Fraction (LVEF)
n=19 Participants
Study subjects missing a day 90 LVEF value and were unable to be assigned to a group.
|
|---|---|---|---|---|
|
All Subjects With Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias During WCD Use
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 360 daysPopulation: Subjects consented and enrolled into the study phase at Day 90.
Observe the occurrence of all sustained VT/VF arrhythmias during WCD use by event. As this was a secondary outcome to describe events during all WCD use, all eligible registry subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.
Outcome measures
| Measure |
Early Recovery
n=279 Participants
Patients improved to LVEF \>35% within the first 90 days following guideline directed medical therapy (GDMT). These patients are expected to end WCD use and not receive an implantable cardioverter defibrillator according to current guidelines.
|
Improvement
n=214 Participants
Patients improved LVEF from start of WCD use (a positive change of at least 5% in LVEF) or have borderline LVEF of 30-35% at day 90. These patients were expected, but not required to continue to use the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Non-improvement
n=90 Participants
Patients show no change, worsening of LVEF or LVEF \<30%. Those on guideline directed medical therapy (GDMT) are expected to be evaluated for an implantable cardioverter defibrillator. Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Unassigned Based on Left Ventricular Ejection Fraction (LVEF)
n=19 Participants
Study subjects missing a day 90 LVEF value and were unable to be assigned to a group.
|
|---|---|---|---|---|
|
All Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias Events During WCD Use
|
5 events
|
1 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: 180 daysPopulation: Subjects consented and enrolled into the study phase at Day 90.
Observe the percentage of patients having other arrhythmias during WCD use, such as asystole and supra-ventricular arrhythmias that are recorded by the device. As this was a secondary outcome to describe events during all WCD use, all eligible registry subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.
Outcome measures
| Measure |
Early Recovery
n=279 Participants
Patients improved to LVEF \>35% within the first 90 days following guideline directed medical therapy (GDMT). These patients are expected to end WCD use and not receive an implantable cardioverter defibrillator according to current guidelines.
|
Improvement
n=214 Participants
Patients improved LVEF from start of WCD use (a positive change of at least 5% in LVEF) or have borderline LVEF of 30-35% at day 90. These patients were expected, but not required to continue to use the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Non-improvement
n=90 Participants
Patients show no change, worsening of LVEF or LVEF \<30%. Those on guideline directed medical therapy (GDMT) are expected to be evaluated for an implantable cardioverter defibrillator. Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Unassigned Based on Left Ventricular Ejection Fraction (LVEF)
n=19 Participants
Study subjects missing a day 90 LVEF value and were unable to be assigned to a group.
|
|---|---|---|---|---|
|
Percentage of All Patients Having Other Arrhythmias
Non-sustained ventricular tachycardia
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Percentage of All Patients Having Other Arrhythmias
Supraventricular tachycardia
|
13 Participants
|
20 Participants
|
4 Participants
|
1 Participants
|
|
Percentage of All Patients Having Other Arrhythmias
Sinus tachycardia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of All Patients Having Other Arrhythmias
Asystole
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 180 daysObserve the effectiveness of the wearable cardioverter defibrillator worn by this population in treating ventricular arrhythmias. As this was a secondary outcome to describe events during all WCD use, all eligible registry subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.
Outcome measures
| Measure |
Early Recovery
n=7 Participants
Patients improved to LVEF \>35% within the first 90 days following guideline directed medical therapy (GDMT). These patients are expected to end WCD use and not receive an implantable cardioverter defibrillator according to current guidelines.
|
Improvement
Patients improved LVEF from start of WCD use (a positive change of at least 5% in LVEF) or have borderline LVEF of 30-35% at day 90. These patients were expected, but not required to continue to use the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Non-improvement
Patients show no change, worsening of LVEF or LVEF \<30%. Those on guideline directed medical therapy (GDMT) are expected to be evaluated for an implantable cardioverter defibrillator. Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Unassigned Based on Left Ventricular Ejection Fraction (LVEF)
Study subjects missing a day 90 LVEF value and were unable to be assigned to a group.
|
|---|---|---|---|---|
|
Efficacy in Treating Ventricular Arrhythmias
Not successfully cardioverted by the wearable cardioverter defibrillator
|
0 Participants
|
—
|
—
|
—
|
|
Efficacy in Treating Ventricular Arrhythmias
Successfully cardioverted by the wearable cardioverter defibrillator
|
7 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 to180, 0 to 270, and 0 to 360 days, or >360 days (up to 14 months)Population: All patients in the Study were assessed for survival at Day 180, 270, and 360, or \>360 days (up to 14 months). Patients who died were adjudicated for cause of death.
Evaluate the effect of wearable defibrillators on 180, 270, and 360-day mortality following discharge in HF patients. Cumulative assessment of survival will be made at these time points for those entered into the study (e.g. up to 180, 270, 360 days, or \>360 days (up to 14 months)). A mortality review will be conducted by independent adjudicators to group all deaths as cardiac or non-cardiac, and sudden or non-sudden. All eligible study subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes. Data collected on deaths after the prespecified final timepoint (n=3) will be labeled \>360 days (up to 14 months). 1 subject completed the study immediately prior to the reported death, hence the different number from the participant flow.
Outcome measures
| Measure |
Early Recovery
n=16 Participants
Patients improved to LVEF \>35% within the first 90 days following guideline directed medical therapy (GDMT). These patients are expected to end WCD use and not receive an implantable cardioverter defibrillator according to current guidelines.
|
Improvement
Patients improved LVEF from start of WCD use (a positive change of at least 5% in LVEF) or have borderline LVEF of 30-35% at day 90. These patients were expected, but not required to continue to use the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Non-improvement
Patients show no change, worsening of LVEF or LVEF \<30%. Those on guideline directed medical therapy (GDMT) are expected to be evaluated for an implantable cardioverter defibrillator. Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Unassigned Based on Left Ventricular Ejection Fraction (LVEF)
Study subjects missing a day 90 LVEF value and were unable to be assigned to a group.
|
|---|---|---|---|---|
|
Mortality Analysis
180 Day cumulative mortality · Cardiovascular death_Sudden
|
2 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
180 Day cumulative mortality · Cardiovascular death_Non sudden
|
1 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
180 Day cumulative mortality · Non-cardiovascular death_Sudden
|
1 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
180 Day cumulative mortality · Non-cardiovascular death_Non Sudden
|
0 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
180 Day cumulative mortality · Unknown death_Non Sudden
|
0 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
270 Day cumulative mortality · Cardiovascular death_Sudden
|
2 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
270 Day cumulative mortality · Cardiovascular death_Non sudden
|
2 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
270 Day cumulative mortality · Non-cardiovascular death_Sudden
|
1 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
270 Day cumulative mortality · Non-cardiovascular death_Non Sudden
|
3 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
270 Day cumulative mortality · Unknown death_Sudden
|
1 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
270 Day cumulative mortality · Unknown death_Non Sudden
|
0 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
360 Day cumulative mortality · Cardiovascular death_Sudden
|
3 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
360 Day cumulative mortality · Cardiovascular death_Non sudden
|
2 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
360 Day cumulative mortality · Non-cardiovascular death_Sudden
|
1 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
360 Day cumulative mortality · Non-cardiovascular death_Non Sudden
|
6 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
360 Day cumulative mortality · Unknown death_Sudden
|
1 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
360 Day cumulative mortality · Unknown death_Non Sudden
|
0 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
>360 Day cumulative mortality (up to 14 months) · Cardiovascular death_Sudden
|
3 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
>360 Day cumulative mortality (up to 14 months) · Cardiovascular death_Non sudden
|
2 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
>360 Day cumulative mortality (up to 14 months) · Non-cardiovascular death_Sudden
|
1 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
>360 Day cumulative mortality (up to 14 months) · Non-cardiovascular death_Non Sudden
|
9 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
>360 Day cumulative mortality (up to 14 months) · Unknown death_Sudden
|
1 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
>360 Day cumulative mortality (up to 14 months) · Unknown death_Non Sudden
|
0 Participants
|
—
|
—
|
—
|
|
Mortality Analysis
180 Day cumulative mortality · Unknown death_Sudden
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 360 daysPopulation: Healthcare utilization events (emergency room visits, hospitalizations, doctor visits etc.) for all patients during the period of the study.
Healthcare utilization (emergency room visits, hospitalizations, doctor visits etc.) on all patients during the period of the study. All eligible study subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.
Outcome measures
| Measure |
Early Recovery
n=3130 Heathcare Utilization Events
Patients improved to LVEF \>35% within the first 90 days following guideline directed medical therapy (GDMT). These patients are expected to end WCD use and not receive an implantable cardioverter defibrillator according to current guidelines.
|
Improvement
Patients improved LVEF from start of WCD use (a positive change of at least 5% in LVEF) or have borderline LVEF of 30-35% at day 90. These patients were expected, but not required to continue to use the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Non-improvement
Patients show no change, worsening of LVEF or LVEF \<30%. Those on guideline directed medical therapy (GDMT) are expected to be evaluated for an implantable cardioverter defibrillator. Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Unassigned Based on Left Ventricular Ejection Fraction (LVEF)
Study subjects missing a day 90 LVEF value and were unable to be assigned to a group.
|
|---|---|---|---|---|
|
Healthcare utilization_type
Doctor visits
|
2640 Heathcare Utilization Events
|
—
|
—
|
—
|
|
Healthcare utilization_type
Hospitalizations
|
247 Heathcare Utilization Events
|
—
|
—
|
—
|
|
Healthcare utilization_type
Emergency room visits
|
125 Heathcare Utilization Events
|
—
|
—
|
—
|
|
Healthcare utilization_type
Observational stay
|
81 Heathcare Utilization Events
|
—
|
—
|
—
|
|
Healthcare utilization_type
UrgiCare visits
|
21 Heathcare Utilization Events
|
—
|
—
|
—
|
|
Healthcare utilization_type
Skilled nursing facility/rehabilitation
|
16 Heathcare Utilization Events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 360 daysPopulation: Events included Hospital, Observation, and skilled nursing facility stays
Length of stay for any hospitalization, observation, skilled nursing facility stays. All eligible study subjects reporting one of these stays were used for this analysis, and grouped by type of stay. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.
Outcome measures
| Measure |
Early Recovery
n=247 Heathcare Utilization Events
Patients improved to LVEF \>35% within the first 90 days following guideline directed medical therapy (GDMT). These patients are expected to end WCD use and not receive an implantable cardioverter defibrillator according to current guidelines.
|
Improvement
n=81 Heathcare Utilization Events
Patients improved LVEF from start of WCD use (a positive change of at least 5% in LVEF) or have borderline LVEF of 30-35% at day 90. These patients were expected, but not required to continue to use the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Non-improvement
n=16 Heathcare Utilization Events
Patients show no change, worsening of LVEF or LVEF \<30%. Those on guideline directed medical therapy (GDMT) are expected to be evaluated for an implantable cardioverter defibrillator. Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Unassigned Based on Left Ventricular Ejection Fraction (LVEF)
Study subjects missing a day 90 LVEF value and were unable to be assigned to a group.
|
|---|---|---|---|---|
|
Healthcare utilization_length of Use
|
3 days
Interval 0.0 to 49.0
|
1 days
Interval 0.0 to 15.0
|
2 days
Interval 1.0 to 22.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 360 daysThe safety objectives will be to compare complications from extended use of the WCD with those of the ICD during the study phase timeframe. All eligible study subjects were used for this safety analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.
Outcome measures
| Measure |
Early Recovery
n=598 Participants
Patients improved to LVEF \>35% within the first 90 days following guideline directed medical therapy (GDMT). These patients are expected to end WCD use and not receive an implantable cardioverter defibrillator according to current guidelines.
|
Improvement
Patients improved LVEF from start of WCD use (a positive change of at least 5% in LVEF) or have borderline LVEF of 30-35% at day 90. These patients were expected, but not required to continue to use the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Non-improvement
Patients show no change, worsening of LVEF or LVEF \<30%. Those on guideline directed medical therapy (GDMT) are expected to be evaluated for an implantable cardioverter defibrillator. Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days.
Wearable Cardioverter Defibrillator: LifeVest Wearable Cardioverter Defibrillator
|
Unassigned Based on Left Ventricular Ejection Fraction (LVEF)
Study subjects missing a day 90 LVEF value and were unable to be assigned to a group.
|
|---|---|---|---|---|
|
Complications From Extended Use
No reported inappropriate shock during study phase
|
597 Participants
|
—
|
—
|
—
|
|
Complications From Extended Use
Inappropriate shock from WCD during study phase (extended use >104 days)
|
1 Participants
|
—
|
—
|
—
|
|
Complications From Extended Use
Inappropriate shock from ICD during study phase
|
0 Participants
|
—
|
—
|
—
|
Adverse Events
Early Recovery
Serious events: 0 serious events
Other events: 8 other events
Deaths: 5 deaths
Improvement
Serious events: 1 serious events
Other events: 14 other events
Deaths: 4 deaths
Non-improvement
Serious events: 0 serious events
Other events: 3 other events
Deaths: 6 deaths
Unassigned Based on Left Ventricular Ejection Fraction (LVEF)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Early Recovery
n=279 participants at risk
Patients improved to LVEF \>35% within the first 90 days following guideline directed medical therapy (GDMT). These patients are expected to end WCD use and not receive an implantable cardioverter defibrillator according to current guidelines.
|
Improvement
n=214 participants at risk
Patients improved LVEF from start of WCD use (a positive change of at least 5% in LVEF) or have borderline LVEF of 30-35% at day 90. These patients were expected, but not required to continue to use the WCD for an additional 90 days.
|
Non-improvement
n=90 participants at risk
Patients show no change, worsening of LVEF or LVEF \<30%. Those on guideline directed medical therapy (GDMT) are expected to be evaluated for an implantable cardioverter defibrillator. Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days.
|
Unassigned Based on Left Ventricular Ejection Fraction (LVEF)
n=19 participants at risk
Study subjects missing a day 90 LVEF value and were unable to be assigned to a group
|
|---|---|---|---|---|
|
Cardiac disorders
Asystole with Inappropriate shock
|
0.00%
0/279 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
0.47%
1/214 • Number of events 1 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
0.00%
0/90 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
0.00%
0/19 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
Other adverse events
| Measure |
Early Recovery
n=279 participants at risk
Patients improved to LVEF \>35% within the first 90 days following guideline directed medical therapy (GDMT). These patients are expected to end WCD use and not receive an implantable cardioverter defibrillator according to current guidelines.
|
Improvement
n=214 participants at risk
Patients improved LVEF from start of WCD use (a positive change of at least 5% in LVEF) or have borderline LVEF of 30-35% at day 90. These patients were expected, but not required to continue to use the WCD for an additional 90 days.
|
Non-improvement
n=90 participants at risk
Patients show no change, worsening of LVEF or LVEF \<30%. Those on guideline directed medical therapy (GDMT) are expected to be evaluated for an implantable cardioverter defibrillator. Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days.
|
Unassigned Based on Left Ventricular Ejection Fraction (LVEF)
n=19 participants at risk
Study subjects missing a day 90 LVEF value and were unable to be assigned to a group
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
2.5%
7/279 • Number of events 8 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
5.6%
12/214 • Number of events 12 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
2.2%
2/90 • Number of events 2 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
0.00%
0/19 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
|
Product Issues
Discomfort
|
0.36%
1/279 • Number of events 1 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
0.47%
1/214 • Number of events 1 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
0.00%
0/90 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
0.00%
0/19 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
|
Product Issues
Inappropriate shock
|
0.00%
0/279 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
0.47%
1/214 • Number of events 1 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
1.1%
1/90 • Number of events 1 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
0.00%
0/19 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
|
Product Issues
Frustration
|
0.00%
0/279 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
0.47%
1/214 • Number of events 1 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
0.00%
0/90 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
0.00%
0/19 • All-cause mortality was assessed up to 14 months; serious and other (not including serious) adverse events were assessed for up to 1 year.
All deaths, Serious Adverse Events, and Other Adverse Events are reported below. All adverse device effects (ADE) were classified by the investigator as anticipated or unanticipated. An unanticipated ADE is any adverse effect not identified by nature, severity, or frequency prior to the study. Commonly reported ADEs in patients having HF were not reported unless deemed to be related to WCD wear. Inappropriate shocks exceeding 3 per 100 patient months are reported as unanticipated ADEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place