LifeVest Safety and Efficacy in Real Life Settings in France

NCT03319160 | Completed Results DMC FDA Device

• 1 other identifier: 90D0130
• Study Type: observational
• Target: 1,164
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Appropriate Shock Events Per Patient

  Appropriate shock events were defined as at least one WCD therapy shock delivered during sustained (at least 30 seconds) ventricular tachycardia (VT) or ventricular fibrillation (VF). All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings. For assessing incidence per 100 patient years, all appropriate shock events were considered.

  start to end of WCD use (3 months typical prescription)

• Risk of Not Receiving Appropriate Shocks When Necessary

  While wearing a WCD, how often does a shock not occur when 1) VF or a sustained (\> 30 seconds duration) VT occurs and 2) the response buttons are not used. Response button use is a surrogate for either a conscious patient or bystander presence.

  from start to end of WCD use (3 months typical prescription)

• Inappropriate Shock Events Per Patient

  Inappropriate shock events were defined as having at least one WCD therapy shock delivered when neither sustained (at least 30 seconds in duration) ventricular tachycardia (VT) or ventricular fibrillation (VF) was not present. All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings. For assessing incidence per 100 patient years, all inappropriate shock events were considered.

  from start to end of WCD use (3 months typical prescription)

Secondary Outcomes (2)

• Survival During WCD Use

  from start to end of WCD use (3 months typical prescription)

• Quality of Life Relative to Health State

  Time of enrollment

Other Outcomes (2)

• Causes of Mortality

  Duration of prescribed device use, up to 3 months.

• Deaths While Wearing the WCD

  Terminal event may have occurred any time during device use, up to 3 months. All data available up to 24 hours prior to the terminal event was used for adjudication.

Study Arms (1)

All LifeVest Users

Patients who were prescribed and used a LifeVest in France

Device: Wearable Cardioverter Defibrillator

Interventions

Wearable Cardioverter Defibrillator DEVICE

A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention

Also known as: LifeVest

All LifeVest Users

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Residents of France All patient who were prescribed a LifeVest were approached for consent. In addition to those prospectively enrolled, patients who had completed LifeVest use prior to the study start were eligible for retrospective enrollment.

You may qualify if:

• Patients receiving a LifeVest prescription in clinical routine for the following indications:
• implantable cardiac defibrillator (ICD) removal due to cardiac device infections,
• a bridge to heart transplantation,
• in the early post-myocardial infarct (MI) period with left ventricular (LV) dysfunction (LVEF \<30%),
• a recent coronary revascularization with LV dysfunction (LVEF \< 30%).
• Patients who have given their consent to participate.

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (2)

Hôpital Européen Georges Pompidou

Paris, France

Location

Clinique PASTEUR

Toulouse, France

Location

Related Publications (2)

• Garcia R, Warming PE, Narayanan K, Defaye P, Guedon-Moreau L, Blangy H, Piot O, Leclercq C, Marijon E; WEARIT-France Investigators. Dynamic changes in nocturnal heart rate predict short-term cardiovascular events in patients using the wearable cardioverter-defibrillator: from the WEARIT-France cohort study. Europace. 2023 May 19;25(5):euad062. doi: 10.1093/europace/euad062.

  PMID: 37021342 DERIVED

• 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.

  PMID: 33257972 DERIVED

MeSH Terms

Conditions

Death, Sudden, Cardiac; Ventricular Dysfunction, Left; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ventricular Dysfunction

Limitations and Caveats

Observational study. Included retrospective subjects (54%). Multiple criteria for inclusion.

Results Point of Contact

• Title: Mike Osz
• Organization: Zoll

mosz@zoll.com

412-968-3333

Study Officials

• Steve Szymkiewicz, MD

  Zoll Medical Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 24, 2017
• Study Start: February 2, 2017
• Primary Completion: September 30, 2018
• Study Completion: March 30, 2019
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-10

Locations

FR (2)