LifeVest Safety and Efficacy in Real Life Settings in France

Sudden Cardiac Death Clinical Trial

— WEARIT France  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03319160
• Other study ID #: 90D0130
• Status: Completed
• Start date: February 2, 2017
• Est. completion date: March 30, 2019

Study information

• Verified date: September 2019
• Source: Zoll Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 1163
• Est. completion date: March 30, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Defibrillation
Wearable Cardioverter Defibrillator

Locations

Country	Name	City	State
France	Hôpital Européen Georges Pompidou	Paris
France	Clinique PASTEUR	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Zoll Medical Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appropriate shocks	Measured by shocks delivered for adjudicated sustained ventricular tachy-cardia (VT) or ventricular fibrillation (VF) episodes.	3 months
Primary	Inappropriate shocks	Measured by shocks delivered for all episodes that are not adjudicated sustained VT or VF episodes	3 months
Secondary	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
Secondary	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