ClinicalTrials.gg
Sign In
CompletedNCT03319160WEARIT-FRUpdated Dec 9, 2024Results posted

LifeVest Safety and Efficacy in Real Life Settings in France

An observational study in Sudden Cardiac Death, Left Ventricular Dysfunction and Cardiac Event, sponsored by Zoll Medical Corporation. Completed at 2 sites in France. Per ClinicalTrials.gov, last updated 2024-12-09.

Sponsored by Zoll Medical Corporation · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,164
Sex
All
01

Study summary

This post-market study is a prospective observational study evaluating the efficacy and safety of the LifeVest in real-life settings.

Read the detailed description

LifeVest has obtained coverage for 4 indications: (i) implantable cardiac defibrillator (ICD) removal due to cardiac device infections, (ii) a bridge to heart transplantation, (iii) in the early post-myocardial infarction period with left ventricular (LV) dysfunction (LVEF \<30%), (iv) and a recent coronary revascularization with LV dysfunction (LVEF \< 30%). There is no current comparator to LifeVest. In France, patients at high risk for sudden cardiac arrest (SCD) and waiting for heart transplant or ICD are hospitalized or discharged home without any particular ECG monitoring. LifeVest has been demonstrated to automatically detect and terminate rapid ventricular arrhythmias. Introduction of LifeVest into the current patient management would definitely improve the clinical outcomes and benefit the patients with temporary risk of SCD. The use of LifeVest was shown to be effective in protecting patients against SCD in the United States. However, the clinical impact of using LifeVest in France remains unassessed. Therefore we are planning to conduct a post-market study in France to provide efficacy and safety data for the reimbursement dossier renewal before April 2017.

02

Conditions studied

  • Sudden Cardiac Death
  • Left Ventricular Dysfunction
  • Cardiac Event
  • Cardiac Arrythmias
03

In context

Death, Sudden, Cardiac

363 studies on the registry are indexed under Death, Sudden, Cardiac; 84 are open to participants now.

This study's enrollment of 1,164 is above the median of 449 across 202 observational studies indexed under Death, Sudden, Cardiac.

Browse Death, Sudden, Cardiac studies →

Lead sponsor

Zoll Medical Corporation is the lead sponsor of 36 studies on the registry; 6 are open to participants now.

Browse Zoll Medical Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Residents of France All patient who were prescribed a LifeVest were approached for consent. In addition to those prospectively enrolled, patients who had completed LifeVest use prior to the study start were eligible for retrospective enrollment.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients receiving a LifeVest prescription in clinical routine for the following indications:

    1. implantable cardiac defibrillator (ICD) removal due to cardiac device infections,
    2. a bridge to heart transplantation,
    3. in the early post-myocardial infarct (MI) period with left ventricular (LV) dysfunction ( \<30%),
    4. a recent coronary revascularization with LV dysfunction (LVEF \< 30%).
  • Patients who have given their consent to participate.

Exclusion criteria

Exclusion Criteria:

  • There are no exclusion criteria for this study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,164 participants (actual)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • All LifeVest Users

    Patients who were prescribed and used a LifeVest in France

    Device: Wearable Cardioverter Defibrillator

Interventions

  • DeviceWearable Cardioverter Defibrillator

    A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention

    Also known as: LifeVest

06

What researchers measure

Primary outcomes

  1. Appropriate Shock Events Per Patient

    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.

    Time frame: start to end of WCD use (3 months typical prescription)

  2. Risk of Not Receiving Appropriate Shocks When Necessary

    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.

    Time frame: from start to end of WCD use (3 months typical prescription)

  3. Inappropriate Shock Events Per Patient

    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.

    Time frame: from start to end of WCD use (3 months typical prescription)

Secondary outcomes

  1. Survival During WCD Use

    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

    Time frame: from start to end of WCD use (3 months typical prescription)

  2. Quality of Life Relative to Health State

    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

    Time frame: Time of enrollment

Other outcomes

  1. Causes of Mortality

    Mortality was adjudicated by 3 cardiologists into these categories: Cardiac, Vascular, or Non-cardiovascular.

    Time frame: Duration of prescribed device use, up to 3 months.

  2. Deaths While Wearing the WCD

    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.

    Time frame: 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.

07

Results

Posted Dec 9, 2024
Limitations and caveats
Observational study. Included retrospective subjects (54%). Multiple criteria for inclusion.

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 flow — Overall Study
MilestoneWCD Users
Started1164
Completed1157
Not completed7
Withdrew: Data not available.7

Outcome measures

PrimaryAppropriate Shock Events Per Patient

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.

Time frame:
start to end of WCD use (3 months typical prescription)
Reported as:
Count of participants · Participants
Appropriate Shock Events Per Patient
ParticipantsAll LifeVest Users
Patients not shocked for VT or VF1139
Patients with 1 appropriate shock event17
Patients with 2 appropriate shock events1
Statistical analysis
  • All LifeVest Users · Incidence per 100 patient-years: 7.5 · 95% CI 6.3 to 8.7Poisson distribution assumed due to the infrequent nature of the events. Number of appropriate shock events: 19 (17 subjects had one appropriate shock event, one subject had two appropriate shock events). Length of exposure: 253 patient-years.
PrimaryRisk of Not Receiving Appropriate Shocks When Necessary

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.

Time frame:
from start to end of WCD use (3 months typical prescription)
Reported as:
Count of units · Recorded instances of VT/VF
Risk of Not Receiving Appropriate Shocks When Necessary
Recorded instances of VT/VFSubjects With VT/VF
Appropriate shock for VT/VF19
Response buttons used for tolerated VT/VF15
Sustained VT, self-terminated before shock8
PrimaryInappropriate Shock Events Per Patient

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.

Time frame:
from start to end of WCD use (3 months typical prescription)
Reported as:
Count of participants · Participants
Inappropriate Shock Events Per Patient
ParticipantsAll LifeVest Users
Patients without inappropriate shock events1149
Patients with 1 inappropriate shock event8
Statistical analysis
  • All LifeVest Users · Incidence per 100 patient-years: 3.2 · 95% CI 1.9 to 4.4
SecondarySurvival During WCD Use

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

Time frame:
from start to end of WCD use (3 months typical prescription)
Reported as:
Count of participants · Participants
Survival During WCD Use
ParticipantsAll LifeVest Users
Survival to end of prescribed WCD use (WCD wearing period)1132
Death during WCD wearing period25
Death after WCD wearing period1
SecondaryQuality of Life Relative to Health State

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

Time frame:
Time of enrollment
Reported as:
Mean · units on a scale
Quality of Life Relative to Health State
units on a scaleProspective Subjects
The LifeVest gives me peace of mind1.96 ± 0.9
I don't worry as much because I know the LifeVest is protecting me2.17 ± 1
I sleep significantly better knowing I am protected by the LifeVest2.51 ± 1.12
I feel more confident returning to my normal daily activities when wearing the LifeVest2.11 ± 0.95
LifeVest has given me the confidence to perform exercise or cardiac rehabilitation2.35 ± 1.03
Wearing the LifeVest makes me take my condition seriously1.66 ± 0.9
I take significantly better care of myself since being prescribed the LifeVest2.14 ± 1.06
I follow lifestyle modification recommendations from my physician1.56 ± 0.68
I would recommend LifeVest to family or friends with a similar medical condition1.67 ± 0.9
Other pre-specifiedCauses of Mortality

Mortality was adjudicated by 3 cardiologists into these categories: Cardiac, Vascular, or Non-cardiovascular.

Time frame:
Duration of prescribed device use, up to 3 months.
Reported as:
Count of participants · Participants
Causes of Mortality
ParticipantsWCD Users
Cardiac cause17
Vascular cause (includes stroke)1
Non-cardiovascular cause6
Unknown (no information available)1
Other pre-specifiedDeaths While Wearing the WCD

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.

Time frame:
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.
Reported as:
Count of participants · Participants
Deaths While Wearing the WCD
ParticipantsDeaths While Wearing the WCD
Arrhythmic cause: primary asystole0
Arrhythmic cause: VF (includes electrical storm)2
Non-arrhythmic cause7

Adverse events

Collected over Data was collected until the end of the prescribed WCD use time (typically 3 months).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All LifeVest Users26/1,157 (2.2%)6/1,157 (0.5%)0/1,157 (0%)
Most frequent serious events
Most frequent serious events
EventAll LifeVest Users
Inappropriate shocksProduct Issues4/1157
AllergySkin and subcutaneous tissue disorders1/1157
Dyspnea with device alertsRespiratory, thoracic and mediastinal disorders1/1157

Baseline characteristics

Age, Continuous
Age, Continuous(years)All LifeVest Users
Mean60.0 ± 11.5
Sex: Female, Male
Sex: Female, Male(Participants)All LifeVest Users
Female183
Male974
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)All LifeVest Users
Enrollment type
Enrollment type(Participants)All LifeVest Users
Prospective enrollment529
Retrospective enrollment628
BMI
BMI(kilograms per meter squared)All LifeVest Users
Mean26.2 ± 5.0
Resting HR
Resting HR(beats per minute)All LifeVest Users
Mean80.0 ± 17.6
Indication for use
Indication for use(Participants)All LifeVest Users
ICD extraction due to infection119
Bridge to heart transplant88
Early after myocardial infarction with LVEF 30% or less647
Early after coronary revascularization with LVEF 30% or less303
LVEF (4 groups)
LVEF (4 groups)(Participants)All LifeVest Users
>45%41
>35% and ≤45%48
>25% and ≤35%483
≤25%577

2 further baseline measures are reported on the registry.

08

Study locations

2 sites
  • Hôpital Européen Georges Pompidou
    Paris, France
  • Clinique PASTEUR
    Toulouse, France
09

References and documents

Publications

  • Garcia R, Combes N, Defaye P, Narayanan K, Guedon-Moreau L, Boveda S, Blangy H, Bouet J, Briand F, Chevalier P, Cottin Y, Da Costa A, Degand B, Deharo JC, Eschalier R, Extramiana F, Goralski M, Guy-Moyat B, Guyomar Y, Hermida JS, Jourda F, Lellouche N, Mahfoud M, Manenti V, Mansourati J, Martin A, Pasquie JL, Ritter P, Rollin A, Tibi T, Yalioua A, Gras D, Sadoul N, Piot O, Leclercq C, Marijon E. Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study. Europace. 2021 Jan 27;23(1):73-81. doi: 10.1093/europace/euaa268. PubMed 33257972 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03319160
Lead sponsor
Zoll Medical Corporation
Responsible party
Sponsor
First posted
Oct 24, 2017
Start date
Feb 2, 2017
Primary completion
Sep 30, 2018
Completion
Mar 30, 2019
Results posted
Dec 9, 2024
Last update
Dec 9, 2024

Study contacts

Steve Szymkiewicz, MD
study director · Zoll Medical Corporation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Death, Sudden, Cardiac →

Other studies from this sponsor

Zoll Medical Corporation →

Start the discussion