LifeVest Safety and Efficacy in Real Life Settings in France

Completed

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

Interventions: Device: Defibrillation

Registration Number: NCT03319160

Lead Sponsor: Zoll Medical Corporation

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1164

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective	Defibrillation	Patients who have already completed use of LifeVest before start of the study
Prospective	Defibrillation	Patients receiving a LifeVest prescription in clinical routine

Primary Outcome Measures

Name	Time	Method
Appropriate Shock Events Per Patient	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.
Risk of Not Receiving Appropriate Shocks When Necessary	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.
Inappropriate Shock Events Per Patient	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 Outcome Measures

Name	Time	Method
Survival During WCD Use	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
Quality of Life Relative to Health State	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