LifeVest Safety and Efficacy in Real Life Settings in France

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

Detailed Description
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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.

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

Conditions
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Sudden Cardiac Death, Left Ventricular Dysfunction, Cardiac Event, Cardiac Arrythmias

Intervention / Treatment
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* Device: Defibrillation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective<br>Patients who have already completed use of LifeVest before start of the study | Device: Defibrillation<br>* Wearable Cardioverter Defibrillator<br>* Other names: LifeVest;|
| Prospective<br>Patients receiving a LifeVest prescription in clinical routine | Device: Defibrillation<br>* Wearable Cardioverter Defibrillator<br>* Other names: LifeVest;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appropriate shocks | Measured by shocks delivered for adjudicated sustained ventricular tachy-cardia (VT) or ventricular fibrillation (VF) episodes. | 3 months | 
| Inappropriate shocks | Measured by shocks delivered for all episodes that are not adjudicated sustained VT or VF episodes | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Measured by the ratio of the number of patients that are alive at the end of the use of the Wearable Cardioverter Defibrillator (WCD) to the total population of patients prescribed the LifeVest | 3 months | 
| 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 | 3 months |