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

ZOLL Medical

Status

Completed

Conditions

Cardiac Arrythmias

Left Ventricular Dysfunction

Sudden Cardiac Death

Cardiac Event

Treatments

Device: Wearable Cardioverter Defibrillator

Study type

Observational

Funder types

Industry

Identifiers

NCT03319160

90D0130

Details and patient eligibility

About

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

Full 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.

Enrollment

1,164 patients

Sex

All

Volunteers

No Healthy Volunteers

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.