NCT03319160: WEARIT-FR

LifeVest Safety and Efficacy in Real Life Settings in France

Completed Results posted Last updated 9 December 2024

What this trial tests

trial testing Wearable Cardioverter Defibrillator in Sudden Cardiac Death in 1,164 participants. Completed in 30 March 2019.

Timeline

2 February 2017

Primary endpoint
30 September 2018

30 March 2019

Quick facts

Lead sponsor	Zoll Medical Corporation
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,164
Start date	2 February 2017
Primary completion	30 September 2018
Estimated completion	30 March 2019
Sites	2 locations across France

Drugs / interventions tested

• Wearable Cardioverter Defibrillator

Conditions studied

• Sudden Cardiac Death — all drugs for Sudden Cardiac Death →
• Left Ventricular Dysfunction — all drugs for Left Ventricular Dysfunction →
• Cardiac Event — all drugs for Cardiac Event →
• Cardiac Arrythmias — all drugs for Cardiac Arrythmias →

Sponsor

Zoll Medical Corporation — full company profile →

Who can join

Eligibility, any sex, with Sudden Cardiac Death or Left Ventricular Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Appropriate Shock Events Per Patient Primary · 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.

Patients not shocked for VT or VF

Group	Value	95% CI
All LifeVest Users	1139

Patients with 1 appropriate shock event

Group	Value	95% CI
All LifeVest Users	17

Patients with 2 appropriate shock events

Group	Value	95% CI
All LifeVest Users	1

Risk of Not Receiving Appropriate Shocks When Necessary Primary · from start to end of WCD use (3 months typical prescription)

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.

Group	Value	95% CI
Subjects With VT/VF	19
Subjects With VT/VF	15
Subjects With VT/VF	8

Inappropriate Shock Events Per Patient Primary · 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.

Patients without inappropriate shock events

Group	Value	95% CI
All LifeVest Users	1149

Patients with 1 inappropriate shock event

Group	Value	95% CI
All LifeVest Users	8

Survival During WCD Use Secondary · 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

Survival to end of prescribed WCD use (WCD wearing period)

Group	Value	95% CI
All LifeVest Users	1132

Death during WCD wearing period

Group	Value	95% CI
All LifeVest Users	25

Death after WCD wearing period

Group	Value	95% CI
All LifeVest Users	1

Quality of Life Relative to Health State Secondary · Time of enrollment

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

The LifeVest gives me peace of mind

Group	Value	95% CI
Prospective Subjects	1.96	± 0.9

I don't worry as much because I know the LifeVest is protecting me

Group	Value	95% CI
Prospective Subjects	2.17	± 1

I sleep significantly better knowing I am protected by the LifeVest

Group	Value	95% CI
Prospective Subjects	2.51	± 1.12

I feel more confident returning to my normal daily activities when wearing the LifeVest

Group	Value	95% CI
Prospective Subjects	2.11	± 0.95

LifeVest has given me the confidence to perform exercise or cardiac rehabilitation

Group	Value	95% CI
Prospective Subjects	2.35	± 1.03

Wearing the LifeVest makes me take my condition seriously

Group	Value	95% CI
Prospective Subjects	1.66	± 0.9

I take significantly better care of myself since being prescribed the LifeVest

Group	Value	95% CI
Prospective Subjects	2.14	± 1.06

I follow lifestyle modification recommendations from my physician

Group	Value	95% CI
Prospective Subjects	1.56	± 0.68

Causes of Mortality Secondary · Duration of prescribed device use, up to 3 months.

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

Group	Value	95% CI
WCD Users	17
WCD Users	1
WCD Users	6
WCD Users	1

Deaths While Wearing the WCD Secondary · 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.

Group	Value	95% CI
Deaths While Wearing the WCD	0
Deaths While Wearing the WCD	2
Deaths While Wearing the WCD	7

Adverse events — posted to ClinicalTrials.gov

Time frame: Data was collected until the end of the prescribed WCD use time (typically 3 months).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

All LifeVest Users

Serious: 6/1157 (1%)

Deaths: 26/1157

Serious adverse events (3 terms)

Reaction	System	All LifeVest Users
Inappropriate shocks	Product Issues	—
Allergy	Skin and subcutaneous tissue disorders	—
Dyspnea with device alerts	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Inappropriate shocks, Allergy, Dyspnea with device alerts.

Data from ClinicalTrials.gov NCT03319160 adverse events section.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study.
   Garcia R, Combes N, Defaye P, Narayanan K, et al · · 2021 · cited 46× · PMID 33257972 · DOI 10.1093/europace/euaa268
2. Dynamic changes in nocturnal heart rate predict short-term cardiovascular events in patients using the wearable cardioverter-defibrillator: from the WEARIT-France cohort study.
   Garcia R, Warming PE, Narayanan K, Defaye P, et al · · 2023 · cited 14× · PMID 37021342 · DOI 10.1093/europace/euad062
3. Wearable cardioverter defibrillator for preventing sudden cardiac death in patients at risk: An updated systematic review of comparative effectiveness and safety.
   Goetz G, Wernly B, Wild C. · · 2023 · cited 10× · PMID 37025482 · DOI 10.1016/j.ijcha.2023.101189