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Completed

NCT Number: NCT03319160

LifeVest Safety and Efficacy 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.

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Key information

Conditions

Sudden Cardiac Death Cardiac Arrythmias Cardiac Event Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Left Ventricular Dysfunction Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Dysfunction Ventricular Dysfunction, Left

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Européen Georges Pompidou, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients receiving a LifeVest prescription in clinical routine for the following indications:
  • implantable cardiac defibrillator (ICD) removal due to cardiac device infections,
  • a bridge to heart transplantation,
  • in the early post-myocardial infarct (MI) period with left ventricular (LV) dysfunction (LVEF <30%),
  • 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

Treatment and study plan

Wearable Cardioverter Defibrillator

Device

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

Other names: LifeVest

Primary outcomes

  1. Appropriate Shock Events Per Patient

    Time frame: 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.

  2. Risk of Not Receiving Appropriate Shocks When Necessary

    Time frame: 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.

  3. Inappropriate Shock Events Per Patient

    Time frame: 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.

Secondary outcomes

  1. Survival During WCD Use

    Time frame: 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

  2. Quality of Life Relative to Health State

    Time frame: 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):

    • = Strongly Agree
    • = Agree
    • = Neither Agree nor Disagree
    • = Disagree
    • = Strongly Disagree

Other outcomes

  1. Causes of Mortality

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

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

  2. Deaths While Wearing the WCD

    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.

    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.

Sponsors and collaborators

Lead sponsor

Zoll Medical Corporation

Industry

Registry information

Official study title

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

Acronym: WEARIT-FR

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Oct 24, 2017
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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