Trial Outcomes & Findings for LifeVest Safety and Efficacy in Real Life Settings in France (NCT NCT03319160)
NCT ID: NCT03319160
Last Updated: 2024-12-09
Results Overview
Appropriate shock events were defined as at least one WCD therapy shock delivered during sustained (at least 30 seconds) ventricular tachycardia (VT) or ventricular fibrillation (VF). All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings. For assessing incidence per 100 patient years, all appropriate shock events were considered.
COMPLETED
1164 participants
start to end of WCD use (3 months typical prescription)
2024-12-09
Participant Flow
All LifeVest users completing use between May 2014 and December 2016 were approached for retrospective enrollment. All patients prescribed a LifeVest January 2017 through March 2018 were approached for prospective enrollment. Recruitment took place in France at 88 cardiology centers.
Participant milestones
| Measure |
WCD Users
Patients prescribed a wearable cardioverter defibrillator for:
1. implantable cardiac-defibrillator (ICD) removal due to device infection,
2. bridge to heart transplantation, or
3. ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) \<30% in the settings of early post-myocardial infarct or after a recent coronary revascularization.
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|---|---|
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Overall Study
STARTED
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1164
|
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Overall Study
COMPLETED
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1157
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
WCD Users
Patients prescribed a wearable cardioverter defibrillator for:
1. implantable cardiac-defibrillator (ICD) removal due to device infection,
2. bridge to heart transplantation, or
3. ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) \<30% in the settings of early post-myocardial infarct or after a recent coronary revascularization.
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|---|---|
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Overall Study
Data not available.
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7
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All LifeVest Users
n=1157 Participants
Patients who were prescribed and used a LifeVest in France
Wearable Cardioverter Defibrillator: A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention
|
|---|---|
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Age, Continuous
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60.0 years
STANDARD_DEVIATION 11.5 • n=1157 Participants
|
|
Sex: Female, Male
Female
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183 Participants
n=1157 Participants
|
|
Sex: Female, Male
Male
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974 Participants
n=1157 Participants
|
|
Enrollment type
Prospective enrollment
|
529 Participants
n=1157 Participants
|
|
Enrollment type
Retrospective enrollment
|
628 Participants
n=1157 Participants
|
|
BMI
|
26.2 kilograms per meter squared
STANDARD_DEVIATION 5.0 • n=1136 Participants • Missing either height or weight information on 21 subjects
|
|
Resting HR
|
80.0 beats per minute
STANDARD_DEVIATION 17.6 • n=1140 Participants • Missing data on 17 subjects
|
|
Indication for use
ICD extraction due to infection
|
119 Participants
n=1157 Participants
|
|
Indication for use
Bridge to heart transplant
|
88 Participants
n=1157 Participants
|
|
Indication for use
Early after myocardial infarction with LVEF 30% or less
|
647 Participants
n=1157 Participants
|
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Indication for use
Early after coronary revascularization with LVEF 30% or less
|
303 Participants
n=1157 Participants
|
|
LVEF (4 groups)
>45%
|
41 Participants
n=1149 Participants • Missing data on 8 subjects
|
|
LVEF (4 groups)
>35% and ≤45%
|
48 Participants
n=1149 Participants • Missing data on 8 subjects
|
|
LVEF (4 groups)
>25% and ≤35%
|
483 Participants
n=1149 Participants • Missing data on 8 subjects
|
|
LVEF (4 groups)
≤25%
|
577 Participants
n=1149 Participants • Missing data on 8 subjects
|
|
LVEF (3 groups)
≥35%
|
147 Participants
n=1149 Participants • Missing data on 8 subjects
|
|
LVEF (3 groups)
≥30% and <35%
|
251 Participants
n=1149 Participants • Missing data on 8 subjects
|
|
LVEF (3 groups)
<30%
|
751 Participants
n=1149 Participants • Missing data on 8 subjects
|
|
NYHA class
Class I
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140 Participants
n=797 Participants • Missing information on 360 subjects
|
|
NYHA class
Class II
|
320 Participants
n=797 Participants • Missing information on 360 subjects
|
|
NYHA class
Class III
|
238 Participants
n=797 Participants • Missing information on 360 subjects
|
|
NYHA class
Class IV
|
99 Participants
n=797 Participants • Missing information on 360 subjects
|
PRIMARY outcome
Timeframe: start to end of WCD use (3 months typical prescription)Appropriate shock events were defined as at least one WCD therapy shock delivered during sustained (at least 30 seconds) ventricular tachycardia (VT) or ventricular fibrillation (VF). All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings. For assessing incidence per 100 patient years, all appropriate shock events were considered.
Outcome measures
| Measure |
All LifeVest Users
n=1157 Participants
Patients who were prescribed and used a LifeVest in France
Wearable Cardioverter Defibrillator: A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention
|
|---|---|
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Appropriate Shock Events Per Patient
Patients not shocked for VT or VF
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1139 Participants
|
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Appropriate Shock Events Per Patient
Patients with 1 appropriate shock event
|
17 Participants
|
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Appropriate Shock Events Per Patient
Patients with 2 appropriate shock events
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1 Participants
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PRIMARY outcome
Timeframe: from start to end of WCD use (3 months typical prescription)Population: All recorded occurrences of VF or sustained VT (\>30 seconds)
While wearing a WCD, how often does a shock not occur when 1) VF or a sustained (\> 30 seconds duration) VT occurs and 2) the response buttons are not used. Response button use is a surrogate for either a conscious patient or bystander presence.
Outcome measures
| Measure |
All LifeVest Users
n=42 Recorded instances of VT/VF
Patients who were prescribed and used a LifeVest in France
Wearable Cardioverter Defibrillator: A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention
|
|---|---|
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Risk of Not Receiving Appropriate Shocks When Necessary
Appropriate shock for VT/VF
|
19 Recorded instances of VT/VF
|
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Risk of Not Receiving Appropriate Shocks When Necessary
Response buttons used for tolerated VT/VF
|
15 Recorded instances of VT/VF
|
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Risk of Not Receiving Appropriate Shocks When Necessary
Sustained VT, self-terminated before shock
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8 Recorded instances of VT/VF
|
PRIMARY outcome
Timeframe: from start to end of WCD use (3 months typical prescription)Inappropriate shock events were defined as having at least one WCD therapy shock delivered when neither sustained (at least 30 seconds in duration) ventricular tachycardia (VT) or ventricular fibrillation (VF) was not present. All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings. For assessing incidence per 100 patient years, all inappropriate shock events were considered.
Outcome measures
| Measure |
All LifeVest Users
n=1157 Participants
Patients who were prescribed and used a LifeVest in France
Wearable Cardioverter Defibrillator: A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention
|
|---|---|
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Inappropriate Shock Events Per Patient
Patients without inappropriate shock events
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1149 Participants
|
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Inappropriate Shock Events Per Patient
Patients with 1 inappropriate shock event
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8 Participants
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SECONDARY outcome
Timeframe: from start to end of WCD use (3 months typical prescription)The number of patients that were alive at the end of the use of the Wearable Cardioverter Defibrillator (WCD) compared to the total population of patients prescribed the LifeVest
Outcome measures
| Measure |
All LifeVest Users
n=1157 Participants
Patients who were prescribed and used a LifeVest in France
Wearable Cardioverter Defibrillator: A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention
|
|---|---|
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Survival During WCD Use
Survival to end of prescribed WCD use (WCD wearing period)
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1132 Participants
|
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Survival During WCD Use
Death during WCD wearing period
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25 Participants
|
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Survival During WCD Use
Death after WCD wearing period
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1 Participants
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SECONDARY outcome
Timeframe: Time of enrollmentPopulation: Data was collected from prospectively enrolled subjects at selected sites. Not all sites participated in the quality of life surveys. Responses were available from 246 of the 529 prospectively enrolled subjects.
Measured through the administration of a patient quality of life survey. This survey has been used previously in a published study of patient quality of life. Agreement score according to 5-point Likert scale (lower is better): 1. = Strongly Agree 2. = Agree 3. = Neither Agree nor Disagree 4. = Disagree 5. = Strongly Disagree
Outcome measures
| Measure |
All LifeVest Users
n=246 Participants
Patients who were prescribed and used a LifeVest in France
Wearable Cardioverter Defibrillator: A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention
|
|---|---|
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Quality of Life Relative to Health State
The LifeVest gives me peace of mind
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1.96 units on a scale
Standard Deviation 0.9
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Quality of Life Relative to Health State
I don't worry as much because I know the LifeVest is protecting me
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2.17 units on a scale
Standard Deviation 1
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Quality of Life Relative to Health State
I sleep significantly better knowing I am protected by the LifeVest
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2.51 units on a scale
Standard Deviation 1.12
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Quality of Life Relative to Health State
I feel more confident returning to my normal daily activities when wearing the LifeVest
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2.11 units on a scale
Standard Deviation 0.95
|
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Quality of Life Relative to Health State
LifeVest has given me the confidence to perform exercise or cardiac rehabilitation
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2.35 units on a scale
Standard Deviation 1.03
|
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Quality of Life Relative to Health State
Wearing the LifeVest makes me take my condition seriously
|
1.66 units on a scale
Standard Deviation 0.9
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Quality of Life Relative to Health State
I take significantly better care of myself since being prescribed the LifeVest
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2.14 units on a scale
Standard Deviation 1.06
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Quality of Life Relative to Health State
I follow lifestyle modification recommendations from my physician
|
1.56 units on a scale
Standard Deviation 0.68
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Quality of Life Relative to Health State
I would recommend LifeVest to family or friends with a similar medical condition
|
1.67 units on a scale
Standard Deviation 0.9
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OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of prescribed device use, up to 3 months.Population: Subjects who died during the device prescription period. The prescriptive period ranged from 1 to 3 months. One death had no information recorded (retrospective group) and was labeled unknown.
Mortality was adjudicated by 3 cardiologists into these categories: Cardiac, Vascular, or Non-cardiovascular.
Outcome measures
| Measure |
All LifeVest Users
n=25 Participants
Patients who were prescribed and used a LifeVest in France
Wearable Cardioverter Defibrillator: A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention
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|---|---|
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Causes of Mortality
Non-cardiovascular cause
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6 Participants
|
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Causes of Mortality
Unknown (no information available)
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1 Participants
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Causes of Mortality
Cardiac cause
|
17 Participants
|
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Causes of Mortality
Vascular cause (includes stroke)
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1 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Terminal event may have occurred any time during device use, up to 3 months. All data available up to 24 hours prior to the terminal event was used for adjudication.Deaths during device use (i.e., physically wearing the WCD) were adjudicated by 3 cardiologists as initiated by asystole, initiated by ventricular fibrillation (VF), or having non-arrhythmic causes.
Outcome measures
| Measure |
All LifeVest Users
n=9 Participants
Patients who were prescribed and used a LifeVest in France
Wearable Cardioverter Defibrillator: A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention
|
|---|---|
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Deaths While Wearing the WCD
Arrhythmic cause: primary asystole
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0 Participants
|
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Deaths While Wearing the WCD
Arrhythmic cause: VF (includes electrical storm)
|
2 Participants
|
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Deaths While Wearing the WCD
Non-arrhythmic cause
|
7 Participants
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Adverse Events
All LifeVest Users
Serious adverse events
| Measure |
All LifeVest Users
n=1157 participants at risk
Patients who were prescribed and used a LifeVest in France
Wearable Cardioverter Defibrillator: A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention
|
|---|---|
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Product Issues
Inappropriate shocks
|
0.35%
4/1157 • Number of events 4 • Data was collected until the end of the prescribed WCD use time (typically 3 months).
Only serious adverse events considered related to device use were collected. Adverse events were defined as serious if it resulted in life-threatening injury/illness, required medical/surgical intervention to prevent life-threatening injury/illness or permanent impairment, required hospitalization, prolonged a hospital stay, was considered a medically important event, or resulted in death.
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Skin and subcutaneous tissue disorders
Allergy
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0.09%
1/1157 • Number of events 1 • Data was collected until the end of the prescribed WCD use time (typically 3 months).
Only serious adverse events considered related to device use were collected. Adverse events were defined as serious if it resulted in life-threatening injury/illness, required medical/surgical intervention to prevent life-threatening injury/illness or permanent impairment, required hospitalization, prolonged a hospital stay, was considered a medically important event, or resulted in death.
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Respiratory, thoracic and mediastinal disorders
Dyspnea with device alerts
|
0.09%
1/1157 • Number of events 1 • Data was collected until the end of the prescribed WCD use time (typically 3 months).
Only serious adverse events considered related to device use were collected. Adverse events were defined as serious if it resulted in life-threatening injury/illness, required medical/surgical intervention to prevent life-threatening injury/illness or permanent impairment, required hospitalization, prolonged a hospital stay, was considered a medically important event, or resulted in death.
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place