Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-02-20 @ 6:24 PM
Study NCT ID:
NCT03319160
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2017-10-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LifeVest Safety and Efficacy in Real Life Settings in France
Sponsor:
Zoll Medical Corporation
Organization:
Study Overview
Official Title:
Post-market Clinical Follow-up Study Evaluating the Efficacy and Safety of LifeVest in Real-life Settings in France
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WEARIT-FR
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: