NCT03319160

LifeVest Safety and Efficacy in Real Life Settings in France

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,164 (actual)
• Sponsor: Zoll Medical Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Sudden Cardiac Death
• Left Ventricular Dysfunction
• Cardiac Event
• Cardiac Arrythmias

Interventions

Type	Name	Description
DEVICE	Wearable Cardioverter Defibrillator	A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention

Timeline

• Start date: 2017-02-02
• Primary completion: 2018-09-30
• Completion: 2019-03-30
• First posted: 2017-10-24
• Last updated: 2024-12-09
• Results posted: 2024-12-09

Locations

2 sites across 1 country: France

Regulatory

• FDA-regulated device study