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

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

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

Study Overview

• Status: Completed
• Conditions: Sudden Cardiac Death; Cardiac Event; Cardiac Arrythmias; Left Ventricular Dysfunction
• Intervention / Treatment: Device: Defibrillation

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 Type: Observational
• Enrollment (Actual): 1163

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Hôpital Européen Georges Pompidou
  • Toulouse, France
    • Clinique Pasteur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Residents of France

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective; Patients who have already completed use of LifeVest before start of the study	Device: Defibrillation; Wearable Cardioverter Defibrillator; Other Names: LifeVest
Prospective; Patients receiving a LifeVest prescription in clinical routine	Device: Defibrillation; Wearable Cardioverter Defibrillator; Other Names: LifeVest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appropriate shocks	Measured by shocks delivered for adjudicated sustained ventricular tachy-cardia (VT) or ventricular fibrillation (VF) episodes.	3 months
Inappropriate shocks	Measured by shocks delivered for all episodes that are not adjudicated sustained VT or VF episodes	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation
• Investigators: Study Director: Steve Szymkiewicz, MD, Zoll Medical Corporation

Publications and helpful links

General Publications

• Garcia R, Combes N, Defaye P, Narayanan K, Guedon-Moreau L, Boveda S, Blangy H, Bouet J, Briand F, Chevalier P, Cottin Y, Da Costa A, Degand B, Deharo JC, Eschalier R, Extramiana F, Goralski M, Guy-Moyat B, Guyomar Y, Hermida JS, Jourda F, Lellouche N, Mahfoud M, Manenti V, Mansourati J, Martin A, Pasquie JL, Ritter P, Rollin A, Tibi T, Yalioua A, Gras D, Sadoul N, Piot O, Leclercq C, Marijon E. Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study. Europace. 2021 Jan 27;23(1):73-81. doi: 10.1093/europace/euaa268.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2017
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: October 19, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Heart Arrest; Death; Arrhythmias, Cardiac; Ventricular Dysfunction; Death, Sudden, Cardiac; Ventricular Dysfunction, Left
• Other Study ID Numbers: 90D0130

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes