LifeVest Safety and Efficacy in Real Life Settings in France (WEARIT-FR)

Post-market Clinical Follow-up Study Evaluating the Efficacy and Safety of LifeVest in Real-life Settings in France

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

Study Overview

• Status: Completed
• Conditions: Sudden Cardiac Death; Cardiac Event; Cardiac Arrythmias; Left Ventricular Dysfunction
• Intervention / Treatment: Device: Wearable Cardioverter Defibrillator

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.

• Study Type: Observational
• Enrollment (Actual): 1164

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Hôpital Européen Georges Pompidou
  • Toulouse, France
    • Clinique Pasteur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

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 (LVEF <30%),
  4. a recent coronary revascularization with LV dysfunction (LVEF < 30%).
• Patients who have given their consent to participate.

Exclusion Criteria:

- There are no exclusion criteria for this study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All LifeVest Users; Patients who were prescribed and used a LifeVest in France	Device: Wearable Cardioverter Defibrillator; A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention; Other Names: LifeVest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	start to end of WCD use (3 months typical prescription)
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.	from start to end of WCD use (3 months typical prescription)
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.	from start to end of WCD use (3 months typical prescription)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	from start to end of WCD use (3 months typical prescription)
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): = Strongly Agree; = Agree; = Neither Agree nor Disagree; = Disagree; = Strongly Disagree	Time of enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Causes of Mortality	Mortality was adjudicated by 3 cardiologists into these categories: Cardiac, Vascular, or Non-cardiovascular.	Duration of prescribed device use, up to 3 months.
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.	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.

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation
• Investigators: Study Director: Steve Szymkiewicz, MD, Zoll Medical Corporation

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2017
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: October 19, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): December 9, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Heart Arrest; Death, Sudden; Cardiovascular Diseases; Ventricular Dysfunction, Left; Death, Sudden, Cardiac; Death; Ventricular Dysfunction; Arrhythmias, Cardiac
• Other Study ID Numbers: 90D0130

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes